How to Review GMP Documents Like a Pro

GMP in pharmaceuticals plays an important role in document maintenance, compliance and product quality. Pharmaceutical documents like batch manufacturer and covered SOP, validation reports, deviation logs and other documents must be reviewed properly and accurately. A single mistake in any document can lead to product lead recall deviation or risk to patient health.

In pharmaceutical manufacturing, document review plays an important role at every stage of manufacturing and analysis. In this post, we will understand the proper way to review GMP documents like a professional, systematically and confidently.

Why Reviewing GMP Documents Is Critical

In GMP, document reviewing is important to ensure that:

• Data integrity is maintained
• Processes are followed as per standard operating procedures
• Deviations are documented, investigated and justified properly
• Final product quality is verifiable
• Compliance with FDA, EMA and WHO GMP standards is achieved

Regulatory agencies focus on documentation, and a lack of adequate review is the top reason for 483 observations and warning letters.

Step-by-Step Process to Review GMP Documents

1. Understand the Document Type and Purpose

Each GMP document has a unique role:
Batch Manufacturing Record (BMR): BMR ensures that the batch is produced as per the approved manufacturing process.
Standard Operating Procedure (SOP): SOP defines the repeatable steps for process consistency.
Validation Protocols and Reports: Validation protocols and reports demonstrate that the process is reproducible and consistent.
Deviation Reports: Deviation reports justify and investigate process abnormalities found and during the manufacturing process.

For any reviewer, it is important to understand the document's intent and the regulatory importance.

2. Check Version Control and Approvals

The most important thing to check during document review is the outdated or unauthorized use of the document. Verify the following:

• Is the correct version number of the document used?
• Is the document approved and signed by an authorized person?
• Are the effective date and control numbers mentioned on the document?

This practice prevents the use of obsolete SOPs and protocols, which can lead to serious compliance issues.

3. Apply ALCOA+ Principles

ALCOA+ stands for:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• + Complete, Consistent, Enduring, Available

Review the document for entries and signature according to the ALCOA+ principles. Check the document for:

• Is each entry attributable to an individual?
• Is the handwriting in the document legible?
• Are corrections made in the document as per good documentation practices?
• Are data and timings in the document real time and traceable?

4. Cross-Check Against SOPs and Protocols

Documents like BMRs and log books should have procedures as defined in standard operating procedures. During review:

• Confirm that all steps during manufacturing were followed as per SOPs
• Any deviation happened must be documented with corrective and preventive action
• Check if raw materials, instruments and parameters match with defined protocol

For example, if a SOP says to perform a visual inspection after compression and coating, then ensure this step is marked completed in BMR.

5. Ensure Legibility and GDP Compliance of Documents

During the review of documents, check if the document follows the general GDP rules.

• No overwriting - use single line strikeouts on the wrong entries
• Corrections made in the document must be signed and dated properly
• Correction fluid should not be used for hiding mistakes
• Entry must be made in indelible ink.
• No blanket should remain empty (write NA if not applicable)

Also, confirm that data in a standard format like DD-MM-YYYYY and time entries should be in 24-hour format, where applicable.

6. Check for Completeness of Documents

The document is considered incomplete if even one required field is missing. Check documents for:

• Signatures of responsible personnel for activity
• Equipment ID and calibration status
• Raw material Batch/Lot number
• Data logs like temperature, pressure, weight and times
• Attachment and support in data like graphs, tables and annexures

Incomplete documentation is common GMP violation and it should be immediately investigated.

7. Review for Consistency of Data

Consistency shows effective process control. Look for:

• Uniformity and time recorded and ideal process durations
• No conflict data in BMRs, logbooks and QC reports
• Reproducibility was maintained in multiple batches

Inconsistent documents can raise issues during audits and inspections.

8. Evaluate Deviation Handling and Their Investigations

Every deviation must be identified, investigated and justified and it should be linked to corrective and preventive action (CAPA). During review, any simple reason of deviation like human error without any deeper analysis should be questioned.

9. Check Sign-offs and Authorization

Document approval in pharmaceuticals is not just a formality but they confirm accountability. Check that:

• Each section of process is signed by the responsible operator or supervisor.
• Review and verification signatures are done with the date.
• Quality assurance has signed and approved the final version of document.

Missing or incorrect sign-offs make the document invalid that can cause issues in batch release.

10. Confirm Traceability

Every document should be traceable:

• From raw material to finished product
• From SOPs to manufacturing steps
• From deviations to CAPA closures
• From test results to source data including instruments and logs

Traceability of the steps ensures the authenticity of the process or analysis.

Common Mistakes to Catch During Document Review

The following are some typical errors that any GMP document reviewer should watch.

• Check if entries are made before the activity is performed
• Any backdated entries in process steps
• Any data mismatch (like weight recorded in balance log does not match with BMR)
• Use of any abbreviations without their explanation
• Any missing attachments or signatures
• Any copy paste errors in electronic documents

A proper document review can help prevent coastal mistakes if they are caught early during review.

Best Practices for Document Reviewers

• You should stay updated with the latest GMP guidelines like FDA, EU-GMP and WHO-GMP.
• Use a checklist for effective review and reduce human errors.
• Don’t review documents in a hurry because a quick review can miss critical details.
• Collaborate with quality assurance, production and quality control teams when there is any doubt.
• Get trained regularly in good documentation practices, data integrity and quality management system documentation.

Document review in a GMP environment is not just ticking the checkboxes; it is safeguarding the product quality and present health. A detailed and traceable document review ensures regulatory compliance and product quality. Apply the principles of this guide when you are reviewing BMRs, SOPs, validation reports or deviation forms to ensure that every document is perfect for internal audits to FDA inspections.

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