How to implement good documentation practice in a GMP regulated plant

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).

– Corrective and preventive action (CAPA);

– Management review of the Quality System;

– 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 d ocument 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.