QA014: SOP FOR GOOD DOCUMENTATION PRACTICES

OBJECTIVE:

To describe the Good Documentation Practices (GDP) to be followed throughout all departments to ensure that all data and records generated, handled, and maintained are complete, legible, traceable, and compliant with EU-GMP, WHO, and national regulatory expectations.

SCOPE:

All GMP/GLP documentation including Batch Manufacturing and Packaging Records, analytical and laboratory data, logbooks, equipment records, validation and calibration documents, training records, and distribution records.
Both manual and electronic records generated at the manufacturing, testing, and warehousing facilities of the company and its approved contract manufacturing organizations.

RESPONSIBILITIES:

Department Heads:

shall responsible for ensuring the implementation of this SOP.
Shall verify the compliance with Good Documentation Practices across all GMP and GLP documentation within their respective departments.

All employees:

Must record data promptly, accurately, and legibly.
To ensure that no falsification, overwriting, or unauthorized correction occurs in any record.

Designee Quality Assurance (QA):

Shall responsible for the preparation, review, and approval of document formats.
Shall maintain master document lists.
To ensure that completed records are reviewed, controlled, archived, and retrievable in accordance with the defined retention policy.

Information Technology (IT):

Shall responsible for establishing and maintaining adequate controls for electronic data, including data security, user access, regular data backups, and maintenance of audit trails as per the requirements of EU-GMP Annex 11.

DEFINATIONS:

Good Documentation Practices (GDP): Good Documentation Practice — a set of practices ensuring documentation integrity and traceability.
ALCOA+ Principle: Data must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
Controlled Copy: An officially issued, tracked, and updated version of a document.

PROCEDURE:

General Principles:

All data must be recorded at the time of activity in a clear and legible manner using indelible blue ink (QA verification in black ink).
Erasable pens, gel pens, pencils, or correction fluid are strictly prohibited.
Every entry shall be signed or initialed and dated by the person performing the activity.
Each page shall display the company name/logo, document number, version number, and page numbering in “Page x of y” format.

Corrections and Amendments:

Wrong entries must be struck through with a single line, ensuring readability of the original text.
The correction shall be written nearby, signed/initialed, dated, and justified briefly if required.
Back-dating and pre-dating are prohibited.
Spoiled or unreadable records shall be re-transcribed with QA authorization; the original copy must be attached and endorsed “Re-copied from original – see attached.

Use of Documents and Records:

All fields must be completed; unused spaces shall be marked “N/A” or crossed diagonally.
Data must never be written on the back of the sheet (except print proofs, labels, etc.).
Each record shall indicate batch number or identification reference for traceability.
For multi-option fields, strike out all non-applicable options with a single line.
Remarks or marginal notes must be initialed and linked with asterisk (*) reference.

Attachments and Printouts:

Affixed labels, printouts, or attachments must bear initials and dates of the person who prepared/verified them.
At least one signature shall overlap both the attachment and base document to verify authenticity.
Attachments shall be filed securely to avoid loss or damage.

Photocopies and Reproductions:

Photocopies of controlled documents shall be made only by QA under document control procedures.
The word “COPY” shall be stamped in red; original signatures shall not be photocopied for approval purposes.

Electronic Data Controls:

Document Control and Retention:

Controlled copies shall be numbered and issued by QA; obsolete copies shall be retrieved and destroyed.
Document retention period: minimum 5 years after batch expiry or as per regulatory/customer requirement, whichever is longer.
Archived records shall be stored in secured, humidity-controlled areas accessible only to authorized personnel.
Retrieval of archived data shall be documented in an archive access log.

Training:

Deviation and non-compliance:

Any deviation from GDP shall be reported through the Deviation Management System and investigated for potential data integrity impact.
Corrective and preventive actions (CAPA) shall be implemented.

Change Management: