Requirements for Good Documentation Practice (GDP)

Requirements for Good Documentation Practice (GDP) :

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.

Importance of documentation:
As per GMP “If it is not written down, then it did not happen”. Document provides information on when, where, who, why and how to complete the task. Document provides evidence proving that the tasks have been completed as they should be.
GDP in Pharmaceuticals
Basic requirements of GDP:
1. Always record the entries at the time of activity simultaneously.
2. Always record date with signature in GMP records.
3. Always use indelible ballpoint pen to record data in GMP records.
4. Always enter the data directly in the GMP records in English language.
5. Never use pencil or erasable or water-soluble ink pen to complete the GMP records.
6. Never use white ink or correction fluid to correct the entry in GMP records
7. Never sign for someone else on any document. Only sign for the work that you have performed yourself.
8. Never back date GMP records.
9. Never discard original raw data of any kind.
10. Never use scratch papers, loose papers or “post it” to record the data.
11. Never discard or destroy any GMP record unless retention period expiry is reached.
12. Documentation and records used throughout the manufacturing process, as well as supporting
processes must meet the basic requirement of GDP.

List of such documents is provided below (List is not limited):
Batch records
Bill of Materials
Specifications
SOPs
Protocols
Test methods
Checklists
Forms / Log sheets
Training assessments
Certificate of Analysis
Technology transfer document
Validation documents
Maintenance records
Calibration records

General requirements
Below mentioned requirements should be applied to all the documentation within the GMP environment.
A. Clearly written documentation:
● All documents must be accurate and written in a manner that prevents errors and ensures consistency.
● If documents are to be used together, e.g. a SOP and a form, then each should reference the other.
● Ensure there is traceability between two or more documents/records using formal document numbers or record identification.
B. Using indelible ink:
● All records must be filled out in indelible BLACK or BLUE ballpoint pen for long term legibility.
● Do not use pencil or ink that can be erased.
C. Legible handwritten Entries:
● A document is unusable if it cannot be read, so care must be taken to ensure that handwriting is legible. All entries must be made at the time the tasks are performed and should be legibly signed and dated.
● The same is true for electronic documents and records – language should be clear and unambiguous.
D. Reviewing and approving:
● To ensure that the information is correct and accurate, documents and records should be reviewed by someone who has performed the task and has proper knowledge. A signature and date by the reviewer/approver confirms that a review has taken place.
● Unsigned documents or records are incomplete and should not be used to perform any task or considered as evidence of a completed task
E. Employee signatures:
● Handwritten signatures must be unique to the individual and listed within the signature register to ensure that the signature is traceable to the concerned employee (or contractor).
● Any employee should not be permitted to sign for another member of staff unless delegated. Signatures must never be forged.
● The management of the signature record should be governed by a procedure and routinely reviewed so that it remains current – new employee should sign the signature register during induction, the signature register must indicate the date employee exit.

Preparation of documents :

1. Clear and concise titles should be used for headings, tables, graphs, etc.
2. Pages in the master document should be numbered as X of Y
3. Full text spelling with the abbreviation in brackets should be used for the first time. Abbreviation may be used in place of full text spelling in remainder of the document.
4. All documents should have the signature and date of the person who prepared the document, reviewed the document and approved the document.
5. All master documents should have effective date, approval date and current version number.
6. Respective SOPs should be followed while preparing the documents.
7. Words that everyone can understand should be used. Unfamiliar words reduce the reader’s understanding of what is written. Definitions of abbreviations should always be included in the document for reference. This is most effectively done by including the definitions in a table format, at the start or end of the document.
8. Ensure that the contents of the document are not squeezed into a smaller area just to limit page numbers. Documents with small margins and no spaces between paragraphs and headings can be difficult to look at, hard and slower to read. Space the contents out so that the type/font is easy to read for all users.
9. When creating a document, consider the context in which the document may be used in the future and whether the reader has enough background information.
10 People remember information best when there is a strong visual prompt, such as a diagram. When the document has to be lengthy, consider using tables to structure the information for easy understanding of the reader.
11. Training of the document should be planned only after approval of document and shall be completed before the effective date.

Issuance and retrieval of GMP records :
1. All the forms associated with the activity should be part of respective SOPs.
2. QA maintains the list of GMP impacting forms and its associated SOP
3. Records for issuance and retrieval of such forms should be maintained.

Recording the time and date in GMP records
1. Time should be entered in 24:00 hour cycle. Record the time in HH:MM format. For Example 11:05 AM should be written as 11:05 and 11:05 PM should be written as 23:05.
2. Date should be entered in DD.MM.YY format. For example 27th July 2013 should be written as 27.07.13.Place “0” before the digit if digit is less than 10 for recording of date.

Data recording in the GMP records :

1. Date and time should be recorded in GMP records as mentioned above.
2. Data should be recorded only in the format duly issued and approved by Quality Assurance.
3. Entries in the logbooks should be made in chronological order. Entries should never be pre-completed.
4. Data recording should be done by trained and authorized person.
5. Data should be recorded as it is displayed on the respective equipment panel.
6. Unusual observation during the activity should be recorded, signed and dated. Same should be reported to area person in-charge and QA.
7. If any observation / signature / date are to be repeated, the same should be rewritten. Ditto (—-“—) marking or “as above” or “do” should not be used.
8. Manual entries should be reviewed and signed by the second person for accuracy and completeness.
9. Raw data / print outs generated during the activity should be signed at the left bottom with date and should be attached with relevant records. Print outs made on the thermal paper should be photocopied. Thermal paper copy along with photocopy should be attached to the concerned record.

Correction of entry in GMP records:

1. Incorrect entries in GMP records should not be overwritten or blocked to make it unreadable.
Always use a single strike out line (For example: Incorrect Entry) to mark the incorrect entry in such a manner that entry remains readable.
2. Correct entry should be written near to the strikeout entry. Person correcting the entry should put the initial signature and date along with corrected entry. Only the person who made the original entry and strikethrough should make correction. If this is not possible, notify to QA.
3. Reason for correcting the entry should also be documented on the record. In case of space constraint in the document the reason for correction should be mentioned on the footer of the record with (*) sign.

Handling of missing entry in GMP records:

1. Entries in the GMP records should be done contemporaneously with the activity. However the procedure mentioned below should be followed in the exceptional case of missing entry in GMP records.
2. Missing entry in the GMP records can be re-entered later if the data are retrievable. (For example: start time of blender is missed by the operator, however the entry for the same is mentioned in the equipment usage log)
3. In such case, entry should be made with clear indication of the date when the activity was performed and the date the activity is recorded on the document.
4. Document the explanation to substantiate the entry and the reason for the delay in recording.
5. Missing entry in the GMP records for non-retrieval data should be handled through event investigation procedure (For example operator missed the reading of drying temperature during the operation, where there is no automatic data recording mechanism in place).

Working with blank or unused space:

Blank/Unused space in the GMP records should be strikeout as below with single line with sign and date to ensure that record can not be added to a later date.
—– Not applicable—-

Cancellation of GMP records:

Cancellation of GMP records should only be allowed in the rare case with the approval of QA and in exceptional cases such as spillage of chemical on the record. Event investigation procedure should be followed to determine further course of action. Reason for cancellation should be documented for cancellation of document and signed by area person in-charge and QA.

GLP vs. GMP: Laboratory Testing Regulations?

GLP vs. GMP: Laboratory Testing Regulations?

�We often confused by the differences between Good Laboratory Practice (GLP) regulation and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. This is understandable, since both GLPs and GMPs cover lab testing but are very different. In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles.

�GLP and GMP regulations pertaining to testing serve two different purposes. The GLPs are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. In contrast, the GMPs are intended to demonstrate to the FDA whether or not individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.

�In general, “lot release” or “lot conformance” testing of regulated products produced for sale, like finished pharmaceuticals, should be done under GMP. Safety testing and efficacy testing should be done under the GLP testing regulations. It is a matter of debate whether validation studies should be done under GLP or GMP. It may depend on what is being validated; in some cases either GLP or GMP may be appropriate.

�GLP vs. GMP?

👉�Study Director

📸GLP:

🖋Single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management.

💰GMP:

✒No Study Director assigned or appointed. No single point of contact is required.

👉� QA Vs. QC

📸GLP:

🖋Single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management.

💰GMP:

🖋Quality Control Unit has responsibility and authority to approve or reject all procedures and aspects of testing/manufacturing. Is overall quality system.

👉�Testing Facility Management

📸GLP:

✒Is responsible for designating a Study Director with appropriate education / training for each study. Ensures there is a Quality Assurance Unit separate from the personnel engaged in the study. Ensures facility, personnel, equipment, etc. is available and complies with the GLPs.

💰GMP:

👉�Supervisors should have proper training. Responsibilities should be in written procedures and followed. Is oversight function.

👉�Type of Testing Conducted

📸GLP:

🖋Open-ended determination of product performance, often for submission to the EPA or FDA for pre-market approval.

GMP:

✒Determination of whether or not the product/sample has met manufacturing specifications.

👉�Facility

📸GLP:

🖋Design and construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups/contamination. Lighting, plumbing, sewage, washing facility regulations are not mentioned under GLPs.

📸GMP:

✒Design construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups/contamination. Lighting, plumbing, sewage, and washing facility requirements are specified under GMPs.

Equipment

📸GLP:

✒Equipment must be appropriate, maintained, and the state of equipment documented to provide study re-constructability. Data-generating equipment is calibrated.

GMP:

✒Equipment must be qualified for use in manufacturing processes. Data generating equipment for product testing purposes is calibrated. The accuracy, sensitivity, specificity, and re-producibility of test methods shall be established and documented.

Standard Operating Procedure (SOP) / Written Procedure

📸GLP:

Drafted by any qualified personnel, approved by Testing Facility Management.

GMP:

Drafted by any qualified personnel, approved by Quality Control Unit.

Standard Operating Procedure (SOP) / Written Procedure

GLP:

Each study requires a specific study protocol indicating study objectives and methods for conduct and is approved by both the Study Sponsor and Study Director prior to initiation. Protocol overrides SOPs.

GMP:

Study-specific protocols are not required. Standard written procedures are followed.

�Master Schedule

GLP:

An index of all studies is maintained by the Quality Assurance Unit.

GMP:

🖋Master Schedule is not addressed.

�Records and Reports

GLP:

signature or initials of personnel conducting all procedures, preparations, calibrations, etc. are required along with dates completed and must be on all records. Records are maintained in secure archives for at least 5 years following date of registration if used to support a marketing permit or 2 years following study completion/termination. Archivist is responsible for archives and ensures security of documentation.

GMP:

Signature of both the personnel conducting procedures and personnel verifying steps of procedures must be on all records (dual control of procedures/records). Records are maintained (not specified in archives) for at least 1 year following product expiration date.

�CAPA System

GLP:

Not required.

GMP:

Required.