Preparing for Successful Inspections is not a one-time Task

Data Integrity app for Pharma Compliance

In Earlier post we understood Types of Inspection carried out in Pharma Industry.

Now in this article we are going to understand Preparation of Successful Inspections & Preparation tips which useful in during your next inspection.

Being inspection ready means that pharmaceutical leaders are committed to managing compliance as part of their company culture.

Will you know when FDA is coming?  It depends upon Pre-approval and routine inspections typically are announced five calendar days in advance.

Compliance follow-up inspections and “for cause” inspections are not pre-announced. FDA inspection of a foreign establishment typically is pre-announced two to three months in advance to allow time for travel and scheduling logistics.

FDA investigators are very competent.

Preparation Tips:

1 Identify escorts for each investigator.  Stay with investigators all the time.  Regulators should not be permitted to roam freely thru the facility both from a safety perspective and a GMP compliance perspective.

2 Ensure that you understand what an investigator is requesting.  You want to provide them with what they want to evaluate, nothing more and nothing less.

3 Assign Notetakers so you can document what each investigator requests, and in what context they make the request.

4 Assign ‘back room’ staff to collect and stage requested documents.  Review each page of each document.  Failure to remove that ‘yellow sticky note’ with problematic comments can have an unfortunate impact or simply be embarrassing.  And, yes, everyone finds these; you cannot be too careful.

5 Do not delay in presenting documents to investigators without informing them of the reason for the delay.  Set expectations for when documents will be provided.  The FDA may deem all products made at a facility to be adulterated if the firm delays, denies, or impedes an inspection.  Warning letters have been issued for this behavior.

6 Assign staff to explain to selected presenters what the investigator is specifically looking for prior to walking into the room with the investigator.  Communicate the context of the request to the company individual who will speak to the investigator.  

7 Timing is everything! Don’t wait until the last minute.

8 Understand your current state of inspection readiness.

9 Use your readiness assessment to think about what activities you prioritize

10 A mock inspection is not a readiness assessment but is a useful part of IR

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Selection of SME (Subject Matter Experts):

  • Competency in answering an investigator’s questions.
  • Performance under stress
  • Adaptability skills
  • Demeanor & attitude of SME

Training of SME

SME trained on below kind of questioners to face inspections

  • Close-ended questions
  • Open-ended questions
  • Leading questions
  • Nondirective or neutral questions
  • Assumptive questions
  • Restatement of questions

Research Inspectors

Research the background of the auditor(s) to gain knowledge of their experience and areas of expertise.

  • Use available resources:
  • Existing Industry contacts
  • Internet Searches
  • Social Media profile (LinkedIn, Facebook etc)

Some important documents to have available include:

  • Equipment calibration and maintenance reports
  • Internal investigations into root causes of production failures
  • Process validation reports
  • Production and process control reports
  • Deviation reports
  • Internal audit reports
  • Statistical evaluation of product data
  • Shipping records
  • CAPA procedures
  • Product recall and rejection reports
  • Customer complaint files
  • Personnel qualifications
  • Training procedures

Verify below things before inspection

  • This was a working day
  • There is documented evidence that analyst & reviewer were working that day
  • Analyst was trained to perform analysis
  • Reviewer was authorized to review
  • Instrument logbook shows instrument was available that day & time
  • Instrument was within calibration
  • Instrument printout confirms date, time, value & instrument ID
  • Instrument printout is initialed by analyst across printout & laboratory record page
  • Color of printer ink is same as other printouts from that day
  • Sample logbook in laboratory details sample ID
  • Sample logbook in plant details sample ID
  • Sample collection time is before sample analysis time
  • Signatures & initials on records conform to master signatures list

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

Innov@tive App

What happens if you not done Software Validation

Data Integrity App for Pharma Compliance

Software validation is part of computerized system validation (CSV). Computerized system validation defined as a documented evidence with a high degree of assurance that the software/computerized system, functions as per software design and user requirements in a consistent and reproducible manner.

 
Software Validation by Functionality

Electronic Record & Signatures

  • Recall/hold functionality
  • Serialization/lot control — traceability features
  • Audit Trail
  • Non-Conformance Reporting (NCR’s)
  • Corrective and Preventive Actions reports (CAPA’s)
  • Calibration and Test

Why Software Validation

1. Safety – Do no harm

  • Software in a medical device to treat an illness can’t fail to dispense the correct treatment
  • Lab software needs to correctly detect and measure impurities
  • Complaints systems need to correctly analyze trends in product quality

2. Effectiveness – Do some good

  • Diagnostic software intended to detect an illness can’t fail to detect
  • Lab software needs to correctly detect the potency (strength) of the product
  • Clinical trial systems records need to correctly reflect patient data from before or after treatment

3. Accuracy – The data must be correct

  • Software that controls a medical imaging system can’t mix up records between patients
  • Distribution systems records need to be accurate regarding what went where to enable recalls
  • Blood management software needs to correctly identify the blood type

4. Integrity – It needs to be transparent who authored, changed or deleted data

  • Software needs to prevent and allow detection of data falsification (i.e., prevent deletion of lab tests, enable audit trails to allow review of changes)
  • FDA inspections require this

5. The software is useful for all the purposes it was intended for

The software has been set up properly and is configured for the documented processes outlined by the particular company.

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What happens if you Not follow the regulatory requirements?

Regulatory agencies have several enforcement actions at their disposal to punish companies who are out of compliance with the regulations.

  • Warning Letter – the most common tool; usually issued after an inspection resulting in a 483, and then an unsatisfactory response
  • Injunction – civil action to prevent production or distribution of the product
  • Product seizure – happens when the FDA believes that a company is likely to distribute adulterated or misbranded product
  • Import restrictions
  • Clinical hold
  • Delay in approval of new products or facilities
  • Consent decree
  • Rejection of application data – often occurs for clinical trials
  • Disqualification of clinical investigators
  • Debarment
  • Criminal prosecution

Across the internet, there are millions of resources are available provide information about almost everything.

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Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

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What is Requirements Traceability Matrix (RTM) & What regulatory say about RTM?

Data Integrity App for Pharma Compliance

What is Traceability Matrix? (TM)

A TM is a document that co-relates any two-baseline documents that require a many-to-many relationship to check the completeness of the relationship.

It is used to track the requirements and to check the current project requirements are met.

What is RTM?

RTM is a method used to establish the relationship between documents. Its purpose is to ensure that requirements have not only been traced to the appropriate design elements but also that requirements have been met through test or other means of verification.

The traceability matrix is a tool both for the validation team, to ensure that requirements are not lost during the validation project, and for auditors, to review the validation documentation.

What do the regulations say?

FDA (Code of Federal Regulations Title 21) and TGA (PE 009-8 – 15 January 2009) currently do not have any specific regulation around requirements traceability.

However, the European Commission (Volume 4 Annex 11 Clause 4.4 (part)) and PIC/S Guide to Good Manufacturing Practice for Medical Products (PE 009-11 1 March 2014 Annex 11 Clause 4.4) do state “User requirements should be traceable throughout the life-cycle.”.

Types of Traceability Matrix

  • Forward traceability: This matrix is used to check whether the project progresses in the desired direction and for the right product.
  • Backward or reverse traceability: The purpose behind this type of traceability is to verify that we are not expanding the scope of the project by adding code, design elements, test or other work that is not specified in the requirements.
  • Bi-directional traceability (Forward + Backward): This traceability matrix ensures that all requirements are covered by test cases. It analyzes the impact of a change in requirements affected by the Defect in a work product and vice versa.  

Advantage of RTM

  • It confirms 100% test coverage
  • It highlights any requirements missing or document inconsistencies
  • It shows the overall defects or execution status with a focus on business requirements
  • It helps in analyzing or estimating the impact on the QA team’s work with respect to revisiting or re-working on the test cases

Across the internet, there are millions of resources are available provide information about almost everything.

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Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

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Types of Inspections in Pharma Industry

Data Integrity App for Pharma Compliance

In Earlier post we understood Overview of Inspection, Purpose, How to Inspection Team, what are the Inspection Steps & Inspection Strategy,

Now in this article we are going to understand Types of Inspection carried out in pharma industry.

Types of Inspection:

The four different types of inspections conducted by FDA are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection. 

Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.

  1. Pre-Approval Inspections (PAI)

These Inspections are conducted after a company submits an application to FDA to market a new product.

These inspections focus on verifying data included in the application, and confirming that the facility is capable of manufacturing said product.

Inspection is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.

The outcome of a pre-approval inspection is that inspectors will recommend for or against FDA approval.

2. Routine Inspections:

Inspections are mandated by law every 2 years for class II and class III device manufacturers. 

They follow a prescribed method known as Quality System Inspection Technique (QSIT).

The purpose of routine inspections is to follow the Quality System Inspection Technique (QSIT), to systematically assess whether your company is following compliance requirements.

If a serious public health risk is identified during a routine inspection, the inspection type may then switch to a “for cause” inspection.

If they find any non-compliance issues or have to issue any 483 observations or warning letters,

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3 Compliance Follow-Up Inspections:

In this inspections review actions taken by a firm/manufacturer in response to a previous inspection that resulted in significant 483 observations or a Warning Letter.

A compliance follow-up is conducted to verify the adequate correction of previous violations, to document continuing violations, or to support future regulatory action.

Is conducted to follow up on information indicating serious problems at firm.\

4 “For Cause” Inspections:

Initiated at the request of CDRH, ORA Headquarters, Regional or District Directive. Dictated by the source of information and may differ from typical QSIT approach.

These inspections are generally more in depth in particular areas than typical QSIT inspections.

Across the internet, there are millions of resources are available provide information about almost everything.

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We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

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Overview of Pharma Inspection from Ground Level

Data Integrity App for Pharma Compliance

What is Inspection?

All Records required under CGMP are subject to FDA inspection. This applies to records generated & maintained on computerized systems, including electronic communications that support CGMP activities.

For example, an email to authorize batch release is a CGMP record that FDA may review.

You must allow authorized inspection, review, and copying of records, which includes copying of electronic data.

Purpose of Inspection:

The purpose of the inspections on manufacturers is to assess their compliance to the GxP.

Inspection Duration;

Depending on the complexity of the company’s operations & purpose of inspection, an inspection generally takes two to five days.

FDA investigator arrives at the site?

  • To see the Top Management
  • Present credentials (identification as an authorized FDA investigator)
  • Issue FDA-482 “Notice of Inspection” (explains FDA’s legal authority to inspect)
  • FDA calls domestic manufacturers up to 5 calendar days before the inspection,
  • FDA contacts foreign manufacturers 2–3 months in advance to schedule inspection
  • Manufacturer may be requested to send Quality System Manual or equivalent for pre-inspection review.

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Inspection Team:

An inspection team generally consists of one lead inspector and assisting inspector(s). Where appropriate, one or more technical specialists may be included.

The lead inspector is responsible for leading the inspection and compiling the inspection report.

The inspection team may also include inspector trainees or observers. All inspection team members are bounded by obligations of confidentiality.

Inspection Steps:

The major stages of inspection processes are

  • Opening Meeting
  • Site Inspection
  • Closing Meeting
  • Opening Meeting:

In the opening meeting, inspectors shall meet the management and key personnel from the manufacturer to discuss the arrangements for inspection.

The lead inspector will typically explain the purpose and scope of inspection, the inspection plan and schedule.

Representative of the manufacturer is required to brief the inspection team on any significant changes since the last inspection.

  • Site Inspection:

The scope of inspection includes inspecting the manufacturing, quality control and storage facilities, interview with personnel and a review of system, documentation and procedures of the manufacturer.

Inspectors may take samples during inspection for analysis by the Government Laboratory when necessary.

  • Closing Meeting:

The inspection team will provide a verbal summary of inspection findings and allow the manufacturer to clarify any deficiencies.

The priorities and timelines for corrective and preventive actions may be discussed.

The manufacturer’s representatives attending the closing meeting normally include the key personnel and the senior management

Inspection Report:

The lead inspector shall prepare an inspection report describing findings, observations and deficiencies.

The report will be reviewed by a senior pharmacist before sending to the manufacturer.

The manufacturer shall normally rectify the deficiencies within the timeframe specified in the covering letter to the report.

Follow-up inspection may be conducted to verify the effectiveness of the manufacturer’s rectification measures.

New Inspection Approach

Focus: Potential for fraudulent activity within your quality systems.

“Guilty until proven innocent” approach to auditing! “Data to good to be true!”.

Assumptions: Will assume fraudulent activity is taking place if they identify weaknesses in your quality systems.

Meta Data is data about data.

Electronic Data (Meta data) is -preferred choice for regulatory authorities as this is the original (“official”) data.

Meta data is dynamic and can be queried / searched / trended.

There is a much higher probability of identifying fraudulent activity within an organization if Meta data is reviewed.

Hard copy (Flat data –printed, pdf, photocopy) is no longer considered to be acceptable by regulatory authorities as this data is not complete and not original.

If you state that paper is your original raw data in your internal procedures this will alert an auditor that you are probably not managing and reviewing electronic (meta) data.

Key Inspectors questions Data Integrity.

• Is electronic data available?

• Is electronic data reviewed?

• Is meta data (audit trails) reviewed regularly?

• Are there clear segregation of duties?

• Has the system been validated for its intended use?

The answers to the above questions will determine whether companies are in compliance with 21 CFR part 11 (Electronic records and signatures).

Leave the Original Meta data in the CD’s & review / approval electronically to avoid increased Data Integrity risk (the paperless lab).

Inspection Strategy:

• Starts with a specific result or record

• Re-create the sequence of events that occurred at time the result was generated using the electronic meta data.

• The auditor will want to know:

• WHO performed the analysis?

• WHAT equipment was used to perform the analysis?

• WHEN the analysis was performed?

•WHY the analysis was performed?

• WHERE the electronic (meta) data is stored?

• Answers to the above may lead to more detailed questioning / inspection.

Facilities that fall under FDA’s eye include:

  • Drug manufacturers
  • Device manufacturers
  • Facilities that conduct studies in people
  • Laboratories that conduct studies in animals
  • Food processing facilities
  • Compounding pharmacies relevant to your FDA inspects
  • Dairy farms
  • Animal feed processors

Across the internet, there are millions of resources are available provide information about almost everything.

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We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

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Activities followed during Retirement & Decommissioning of instrument/equipment in pharma industry.

Data Integrity App for Pharma Compliance

The retirement and decommissioning process is the last stage in application or product life cycle management.

Many different factors can trigger this event such as technological advancement, business needs & acquisitions/mergers while the underlying business process can become obsolete, etc.

In regulated life science companies, the retirement & decommissioning process should be planned & documented.

Associated records need to be retained as per the approved validation plan & procedures. The record retention requirements can vary depending on the type of records.

What is Retirement:

Retirement of GxP assets & computer systems should be planned carefully so that there is no disruption to business users & they are smoothly migrated to a new system.

Organizations plan & execute the retirement process through the required approval process. The retirement schedule will be created & approved within the system.

The schedule can be created with record retention periods & associated user groups alerted for the planned retirement schedule & required activities.

Main activities during a standard retirement process:

  • System allows users to create retirement schedules for the GxP assets & associated records.
  • Different schedules can be created based on the type of asset and associated records. Records can have separate retention periods.
  • The retirement schedule can be reviewed & approved.
  • Once the documents are retired, the associated documents are retained in the system until the scheduled record retention period is attained.
  • Retirement data & documents are available for audits with real-time status.
  • Approved Validation procedures & policies for the retirement and decommissioning process can be enforced through the software system.

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What is Decommissioning:

Decommissioning is a general term for a process to remove something from active status.

There are many factors & requirements to consider in this process, documentation, process management, Environmental, Health, and Safety (EHS), compliance, financial, operational, maintenance, supporting contracts & interfaces with other facilities & site utilities.

Main activities preceding a decommissioning process

In order to accomplish an efficient & quick decommissioning process, there are several activities which must be carried out before the process starts. These essential activities are:

  • Identification and management of all the GMP documentation associated with equipment, systems and applications in any format or medium (electronic and paper).
  • Identification and management of all GMP data generated during the life cycle of the equipment and systems.

Main activities during a standard decommissioning process:

  • Identification of instruments, equipment, systems and applications to decommission;
  • Classification or categorization of the instruments, equipment, systems and applications according to their complexity and the way in which the information has been stored;
  • Preparation of the decommissioning documents related to instruments, equipment, systems and applications according to their complexity and category:
  • Decommissioning Checklists: these are documents written for non-computerized systems, equipment and applications or for systems which do not store any information.
  • Decommissioning Plans: these are documents written for computerized equipment, applications and systems or systems which store information.
  • Management of the information stored in equipment, systems and applications.

Across the internet, there are millions of resources are available provide information about almost everything.

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Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

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Innov@tive App

One steps ahead from Paper base Logbook to E Logbook Management

Data Integrity App for Pharma Compliance

Log management is one of the most essential elements of Quality management system.

Documenting, maintaining equipment usage & cleaning log with audit trail is mandatory requirement as per regulatory.

Proper log management of the equipment in the organization is necessary to ensure accurate, reliable, and timely manufacturing details of products

Paper-based equipment use logs come with baggage. Many logs are not completed appropriately and create GDP compliance issues.

These problems require extra hours of work

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Challenges with manual paper-based logbooks

  • Paper-based logbook data entry across multiple locations
  • Makes validation difficult,
  • Creating waste in the forms of financial loss,
  • Reduce productivity,
  • Human error,
  • Irrelevant information,
  • Loss of customer confidence,
  • Work redundancy,
  • Inaccurate estimates for production quantities

Benefits of Electronic Logbook Management

  • The system allows for the entire process to be monitored during the course of a production.
  • Reduction of paper and manual data entry job
  • There are multi-lingual capabilities
  • No need for printing & binding all information is available in system itself.
  • Electronic logbooks guarantee integrity of data contained in it.
  • Logbooks cannot be lost or misplaced
  • Manage Batch manufacturing time recording online
  • Alerts and Notifications

Across the internet, there are millions of resources are available provide information about almost everything.

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Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

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Is your instrument is calibrated? Factors which decide calibration frequency?

https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

Calibration is a process that demonstrates a particular instrument or device produces results within specified limits, as compared to those produced by a traceable standard over an appropriate range of measurements.

Calibration activities must be performed with qualified instruments by an accredited laboratory.

In calibration set of operations are performed under specified conditions & produces instrument or device results within specified limits.

An accredited laboratory can ensure that all the calibration services and activities are performed with qualified instruments.

Main Objectives of Calibration:

  • It checks the accuracy of an instrument.
  • It determines the traceability of the measurement.

Factors which Determining calibration frequency

  • Criticality of the measurement location: Make sure to calibrate the more critical locations more frequently than the less critical ones.
  • Stability history of the instrument: Check how often calibration was required in the past. This will provide a good framework to plan and schedule calibration.
  • Workload and operating conditions: Instruments with too much workload or extreme operating conditions call for more frequent calibration than others.
  • Before extremely important measurements: Calibration is a good idea before a particularly important measurement has to be taken.
  • Sudden unforeseen events: If an electric fault, external conditions that are out of one’s control such as drastic weather and pressure changes, a fall or any other impact occur, conduct a calibration process immediately.
  • Discrepancies suspected in the final product: Any discrepancy or shift from acceptable performance criteria is an indication to calibrate the instrument. Slight variations are normal, but anything that crosses an acceptable limit means calibration is needed immediately.

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What happens without Calibration:

If an instrument is not calibrated for a long time, the following issues can occur:

  • Ambiguous quality: The measurements will become faulty, and discrepancies will be seen, which will reflect on the final product. This will result in questionable quality of the products.
  • Safety issues: In the pharmaceutical industry, the quality of the final product holds extreme importance because it can affect thousands of lives. Non-calibrated instruments will cause wrong measurements of raw materials when producing medicines or instruments of sensitive nature such as thermometers, which can cause serious safety threats to the final users.
  • Misuse of resources: Non-calibrated instruments will waste time and resources, which prove  expensive in the long run.
  • Downtime increases: When the final products show deviance from the required quality, shutting down the process to conduct a complete recalibration is required. This results in increased downtime. Regular calibration will eliminate that and help in detecting warning signs before they affect the final product or cause significant damage.
  • Risk of litigation: When customers realize the product they received does not match up to the expected quality or if they suffer seriously due to the low quality of the pharmaceutical products, they will return the product and ask for a full refund or press legal charges due to the damage caused. This will affect reputation and increase costs. It might even call for a product recall, which is also expensive.

Why calibration is important:

Calibration defines measurement parameters such as range, accuracy and precision of an instrument. It is one of the major parts of pharmaceutical manufacturing standards and quality assurance because of these reasons:

With regular use and time, instruments and devices used in the industry will undergo damage, which causes a shift in the measurements. Regulatory inspection will help in tracking the shifts and rectifying through calibration.

When the instrument does not perform within the acceptable range of error, its quality will be greatly affected. Calibration guarantees the quality is not affected by constant errors. This is crucial for processes where the quality of measurement is directly related to the quality of the product.

Certain measurements will be affected by ambient condition such as temperature, pressure and humidity. A change in the surrounding atmospheric conditions will cause a drift in the measurement, and regular calibration will keep this drift within acceptable limits.

Periodic calibration will ensure the measurements and outputs achieved are accurate at all times without affecting the quality of the final product.

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

Innov@tive App

Factors which never missed in Periodic System Review

Data Integrity App for phama compliance

Periodic System Review /Evaluation

Conducting periodic reviews on GxP systems, assets and/or processes that have already been validated is a critical aspect in any validated environment.

It is important to review a system or process for changes both physical and procedural in order to verify that a system or process is operating as expected.

For the most part, management of periodic reviews is achieved using spreadsheets and other paper-driven tools.

This in turn equates to reliance upon a single user or group of users to ensure that periodic reviews are completed on time and documented accordingly. Through this reliance on human interaction the possibility of errors heightens and risk increases.

In this way human errors are removed from the process ensuring that users are aware in real time of the status of any periodic review.

  • Periodic review for Computer System
  • Periodic review for Equipment and Utilities.

Periodic System Review is to ensure that the computer system remains compliant with regulation, is fit for its intended use and satisfies company policies and procedures.

Both the FDA and EU GMP’s detail the requirement for demonstrating that a computer system remains in a validated state throughout its operating history.

FDA 21 CFR 211.68(b) States:
“Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system.”

EU Annex 15 States:
“Facilities, systems, equipment and processes, including cleaning, should be periodically evaluated to confirm that they remain valid. Where no significant changes have been made to the validated status, a review with evidence that facilities, systems, equipment and processes meet the prescribed requirements fulfils the need for revalidation.”

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Frequency of Periodic Review

The frequency of Periodic Reviews based on the Complexity, Criticality, Novelty, and Operating History of the computer system.

For example an automated control system (Category 4 / 5) the computer system periodic review should be performed more frequently than an off the shelf item.

The frequency of review should be defined with a minimum and maximum time between reviews. For example a scale of 1 to 4 years can be set for the review period.

Only new GAMP category 4 and 5 Computer Systems would have an annual review period.

Category 4/5 is configurable software so periodic review should be annually performed. For non-configurable systems starting with a frequency of 2 years when first installed through to a maximum 4 years once a stable operating history is established.

Method of periodic review:

The first is the traditional periodic review of the computer system which is performed at a predefined period.

The second is continual monitoring and trending with a review report.

Periodic system review considers:

  • Physical & Logical security
  • Relevant Documentation (Incident, Deviation, change control, SOP’s)
  • Backup, Restore& Disaster recovery
  • Validation Status
  • Inventory (system ID, location & application software )
  • Roles and Responsibilities
  • Service Agreements
  • Validation/Qualification and Project Deliverables:
  • System Control Procedures
  • Audit Trail management
  • Incidents, Problems
  • Changes, Upgrades
  • Security, User Access, User Administration
  • User Guides
  • System Access Training
  • Archived Data

Periodic Review performed by

  • Process Owner – Laboratory person who is responsible for the system
  • System Owner –Person responsible for the availability and support of the system
  • IT – System/IT Administrator
  • Quality Assurance

Benefits of Computer System Periodic Review

  • Quality and the Business
  • Improve the operation
  • Maintain compliance
  • Support the continuous improvement

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Is Qualification is necessary & when Re-Qualification performed?

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Qualification is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results

It is the process used to establish confidence that the equipment is capable of consistently operating within established limits and tolerances.

Need of Qualification

  • To manufactured a quality product
  • Proof “suitability for intended use”
  • Regulatory requirements
  • Cost effective

Steps in Qualification

  • Defining User Requirements (URS) Defining Functional Requirements for given User requirements (FRS)
  • Defining Design based on URS & FRS (DQ)
  • Factory Acceptance Test at the site of manufacturer (FAT)
  • Site Acceptance Test at the site of user (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

User Requirement Specification

User Requirement Specifications consist of Design Specifications and Functional Specifications.  Design Specifications provide explicit information about the design requirements for equipment e.g. the dimensions, material of construction, layout, etc. Functional Specification denotes how each feature of the equipment/system must function.

Factory Acceptance Test (FAT)

  • Checks for completeness of installation.
  • Verification of URS with the actual.
  • Proof of functionality, by either a conventional function test or by simulation.
  • Verification of documents (availability and quality).
  • Overall Review/Inspection.

Site Acceptance Test (SAT)

  • Verification of equipment design
  • specifications of received equipment at site of User by received documents/drawings from Manufacturer / vendor
  • Physical verification

Design Qualification (DQ)

It includes activities that define the design elements of the instruments such as functional and operational specifications as well as vendor selection criteria.

DQ can be performed by the manufacturers, developers or even the end users.

Installation Qualification 

IQ comprises all activities during the installation of the instrument.

IQ checks whether the environment where it is installed is suitable, if the instrument is in accordance with the desired specifications and if the installation procedures have been complied with.

Operational Qualification 

It involves collecting document evidence showing that the installed instrument’s performance in the chosen environment will be according to the criteria specified in operational specifications.

Performance Qualification 

It requires measuring if the instrument is performing its intended purpose against the activities documented in the PQ stage, which consists of maintenance, change control and calibration.

Reason Re-Qualification

  • To address deficiencies observed in an executed qualification
  • Need for additions in qualification test criteria
  • To qualify changes done in the equipment or a process involving the equipment
  • Failure
  • CAPA
  • Findings/Recommendations from Inspections/Audits/ PQR, etc.
  • Inputs from Preventive Maintenance/Calibration Program
  • Equipment Up-gradation

Across the internet, there are millions of resources are available provide information about almost everything.

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Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

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