Saturday, August 27, 2016

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
Test methods
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 u