Pharmaceutical related documents (e.g., batch production records, SOPs involved, validation reports, deviation records and other documents) must be properly and accurately reviewed.

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Review the step-by-step process of GMP documentation

1. Understand file types and uses

Each GMP document has a specific purpose: Batch Production Record (BMR): To ensure that batches are produced in accordance with the approved production process.

Standard Operating Procedure (SOP): Repeatable steps that ensure process consistency.

Validation plan and report: to demonstrate the repeatability and stability of the process.

Deviation report: explain and investigate the abnormal process found in the production process.

For any auditor, understanding the intent of the document and the importance of the regulatory layer is critical.

2. Check version control and approval status

During document review, focus on checking whether the document is outdated or used without authorization.

The following items need to be confirmed:

Is the file in the correct version number?

Is the document approved and signed by authorized personnel?

Is the effective date and control number indicated on the document?

Such checks can avoid the use of outdated SOPs and protocols and prevent serious compliance issues.

3. Apply the ALCOA ++ principle

Attributable

It should be possible to identify the individual or computerised system that performed a recorded task and when the task was performed. This also applies to any changes made to records, such as corrections, deletions, and changes where it is important to know who made a change, when, and why.

Legible

All records should be legible – the information should be readable and unambiguous in order to be understandable and of use. This applies to all information that would be required to be consid- ered complete, including all original records or entries. Where the ‘dynamic’ nature of elec- tronic data (the ability to search, query, trend, etc.) is important to the content and meaning of the record, the ability to interact with the data using a suitable application is important to the ‘availability’ of the record.

Contemporaneous

The evidence of actions, events or decisions should be recorded as they take place. This doc- umentation should serve as an accurate attesta- tion of what was done, or what was decided and why, i.e. what influenced the decision at that time.

Original

The original record can be described as the first capture of information, whether recorded on pa- per (static) or electronically (usually dynamic, depending on the complexity of the system). In- formation that is originally captured in a dy- namic state should remain available in that state.

Accurate

Records need to be a truthful representation of facts to be accurate.

Ensuring records are accurate is achieved through many elements of a robust pharmaceuti- cal quality system.

This can be comprised of:

equipment related factors such as quali- fication, calibration, maintenance, and computer validation.

policies and procedures to control ac- tions and behaviours, including data re- view procedures to verify adherence to procedural requirements.

deviation management including root cause analysis, impact assessments and CAPA.

trained and qualified personnel who un- derstand the importance of following established procedures and document- ing their actions and decisions.

Together, these elements aim to ensure the accu- racy of information, including scientific data that is used to make critical decisions about the quality of products.

Complete

All information that would be critical to recreat- ing an event is important when trying to under- stand the event. It is important that information is not lost or deleted. The level of detail required for an information set to be considered complete would depend on the criticality of the infor- mation. A complete record of data generated electronically includes relevant metadata.

Consistent

Information should be created, processed, and stored in a logical manner that has a defined consistency. This includes policies or proce- dures that help control or standardize data (e.g. chronological sequencing, date formats, units of measurement, approaches to rounding, signifi- cant digits, etc.).

Enduring

Records should be kept in a manner such that they exist for the entire period during which they might be needed. This means they need to remain intact and accessible as an indelible/du- rable record throughout the record retention pe- riod.

Available

Records should be available for review at any time during the required retention period, acces- sible in a readable format to all applicable per- sonnel who are responsible for their review whether for routine release decisions, investiga- tions, trending, annual reports, audits or inspec- tions.

Traceable

Traceability is the ability to trace the his- tory, modification or location of data by means of recorded identifications.

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-YYYY 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 ocument 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.