How to implement good documentation practice in a GMP regulated plant

Kazi
Last modified: April 2, 2024

Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records.

To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements. Standard operating procedures (SOP) shall be established and maintained at each GMP site to define the responsibilities and the workflow processes for GMP documents and records.

Who are responsible for developing good documentation practice?

Everyone in the GMP facility is responsible for maintaining good documentation practice. However, the GMP site quality team is primarily responsible for developing and implementing good documentation practice. The quality team sould be responsible for:

i. Ensuring there is a controlled, documented system to manage GMP documents and records in compliance with local regulations; and

ii. Reviewing and approving standard operating procedures that describe the process for preparation, approval, maintenance and archiving master documents.

iii. Completing, reviewing, assigning disposition, retaining and archiving the associated records.

SOPs shall be established and maintained that define the requirements for GMP documents and records including, but not limited to, the following:

i. Documents applicable to active pharmaceutical ingredients (API), drug products and medical devices:

– Direct impact system facility, utility and equipment drawings;

– Stability and validation protocols and reports

– Material control documents; and

– Test methods (TM);

ii. Records applicable to APIs, drug products and medical devices:

– Equipment Cleaning, Maintenance and Use Logs;

– Training Records;

– Complaint Records;

– Distribution Records;

– Change Control Records;

– Records of Market Actions;

– Laboratory Test Records;

– Equipment and Instrument Calibration Records;

– Deviation Investigation Records; and

– Batch Production Records and Control Records;

In addition to the above documents, the following documents should also be established and maintained for APIs and Drug Products:

– Master batch record documents (e.g., Master Manufacturing Instructions and Master Packaging Instructions).

– Design controls;

– Corrective and preventive action (CAPA);

– Management review of the Quality System;

– Risk management;

– Purchasing controls;

– Post marketing surveillance;

– Device master records (DMR); and

– Device history records (DHR).

GMP documents shall be reviewed and approved by the site quality team to assure the documents are in compliance with regulatory and registration requirements.

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Document management system in good documentation practice

Good document management system is pre requisite to establish a compliant good documentation practice. Document management system shall be established and maintained to assure that GMP related documentation:

i. Is complete and contains all required data;

ii. Is accurate and acceptable;

iii. Is uniquely identified and version controlled to ensure that the correct document is used;

iv. Has assigned document identification (ID) numbers that are not reused; and

v. Follows SOPs for the documentation (document lifecycle):

– Creation and/or change;

– Review and approval;

– Becoming Effective

– Distribution;

– Obsolescence;

– Archival; and

– Has an audit trail.

vi. Memos to File shall only be used if there is not an approved document that is designed to provide the required information. Examples of approved documents include Laboratory Investigation Reports (LIR) and Deviation Investigation Reports.

vii. Documentation standards and SOPs for Handwritten Entries on GMP records shall be established and maintained at each GMP site.

Document management system requires the GMP site to create a document control systems which should include the following:

i. A process to assure that documents are unambiguous in scope, title, contents and purpose;

ii. A process that prohibits conflicting or redundant information among documents;

iii. A process to prohibit handwritten GMP documents except for handwritten approval entries for master documents or handwritten data entries on records;

iv. Defined responsibilities for review and approval of documents at the site;

v. Site quality team should verify that the documents meet regulatory and registration requirements;

vi. Defined document requirements for creating, approving, assigning effective date, distributing, revising, obsoleting, archiving and deleting;

vii. Clear distinction between master documents, official copies and unofficial copies;

viii. Periodic Review of documents and measures to prevent the use of obsolete or superseded documents;

ix. Requirements to assure only one version of a document is effective at one time;

x. Process for change control;

xi. Process for version and revision control and for effective dates;

xii. Defined review periods that are in compliance with site and regulatory requirements; and

xiii. Requirement to assure every page of the document is numbered.

Good practice for handwritten entries on GMP records

Good documentation practice for handwritten entries on GMP records shall include but not be limited to, the following:

i. Use of indelible ink. Erasable ink, non-waterproof ink, highlighters and pencil are prohibited;

ii. When signing or initialing for record information, colleagues must also include date;

iii. Unambiguous author, date and time entries;

iv. Consistent date and time format according to site SOP;

v. Entries made immediately upon completion of the recorded task, step and/or process;

vi. Clear, legible, accurate, complete and factual entries;

vii. Entries made directly onto the official record. The use of scrap paper is prohibited;

viii. Correction made by drawing a single line through an incorrect entry, entering the correction, including an explanation for the change if it is not obvious and signing and dating or initialing and dating the correction;

ix. Correction to a completed record requires re-approval of that record;

x. Use of correction fluid or tape or any other obscuration of the original entry is prohibited;

xi. Predating or postdating documents is prohibited;

xii. Spaces shall not be left blank. A single line or N/A shall be included where no data is required. In the case of records that are clearly and explicitly designed such that it is clearly evident that only one of multiple options is possible, lining out an unused option may not be required;

xiii. Use of ditto (-“-) marks for repeated entries is prohibited. All results shall be fully recorded;

xiv. Signatures, initials, and dates are authentic and original and are maintained in a current signature or initial file; and

xv. Signature by a colleague on behalf of the original person performing the action constitutes a second signature and shall follow a defined format.

Audit trail in document control

An audit trail shall be created and maintained following establishment of standard operating procedures to assure that changes to data and/or reviews and approvals are properly recorded.

The audit trail, at a minimum, must document the reason and justification for the change, who made the change, who approved the change and the date the change was made and must not obscure the original data.

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Good documentation practice in memos and emails

If a memo to file must be used to record an event, issue data or other information, the following requirements should be met:

i. The document should be in paper format;

ii. Be addressed to a responsible individual’s attention;

iii. Include a distribution list and reference any related filed copies, where applicable;

iv. Include a specific title, product and/or Lot reference;

v. Be signed and dated by the author; and

vi. Be filed in a specific lot file, or in a subject or product file when there is no specific lot associated with the document.

Note: Memo to file may be used as supporting documentation for an approved document.

For quality related functions, email shall only be used as a communication tool.

i. Email shall not be used to record GMP-related raw data or initial observations in respect of product safety and quality;

ii. Email shall not be used to record authorization of GMP decisions that impact regulated activities;

iii. Email shall not be used to record document approval; and

iv. Email can be used to add comments and/or annotations to draft documents.

Email can be used to communicate GMP decisions that impact regulated activities if the email is accompanied by documented approval of the decision in the form of an unalterable attachment [e.g., a scanned memo or completed form containing handwritten signatures and dates attached to the email as a portable document format (PDF)] or by a faxed approval containing handwritten signatures and dates.

Completed GMP documents and records must be reviewed and approved for the following:

– Completeness;

– Presence of required data;

– Accuracy;

– Acceptability of data; and

– Compliance with Site SOPs

Key points about good documentation practice

– A good documentation system is the cornerstone of a GMP compliance system.

– All personnel must follow the written and approved documents in the day-to-day operation of the manufacturing facility.

– It is the responsibility of management to provide a documentation system that conforms to the GMP requirements and then train the users in the requirements of the system.

– It is your responsibility to understand the documents and use them correctly.

– When you sign or initial a record saying that you carried out a process, you are certifying that the process was carried out according to the written and approved procedures.

– When you sign or initial a checking step in a record, you are saying that you observed what was done, and can verify that it was done correctly.

– Remember: if it’s not documented, it wasn’t done.

Author: Kazi Hasan

Kazi is a seasoned pharmaceutical industry professional with over 20 years of experience specializing in production operations, quality management, and process validation.

Kazi has worked with several global pharmaceutical companies to streamline production processes, ensure product quality, and validate operations complying with international regulatory standards and best practices.

Kazi holds several pharmaceutical industry certifications including post-graduate degrees in Engineering Management and Business Administration.

2 thoughts on “How to implement good documentation practice in a GMP regulated plant”

Terri Taricco-Cropp says:

March 17, 2023 at 11:32 pm

Do you have any examples of Master Manufacturing Records or Templates for a food based business.?

Reply
1. admin says:
  
  March 18, 2023 at 9:43 am
  
  Hi, Unfortunately, our procedures cover pharmaceutical manufacturing processes. You may find the GMP fundamentals are very similar. While the process steps for food production are unique. Sorry.
  
  Reply