Good Documentation Practices SOP
Good documentation practice (GDocP) is a key component of regulatory compliance, including data integrity assurances. good documentation practices are ingrained in all work processes and operations, ranging from research and development to the actual production and final testing. During this time, manufacturers systematically prepare, review, approve, issue, record, and store documents detailing every activity undertaken to produce pharmaceutical products. Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles.GRK/GDocP is mandatory to ensure that your documentation — and your products — meet industry standards. Meeting good documentation practice requirements is also an important part of fulfilling other legal responsibilities in the pharmaceutical & medical devices sectors.
Objective of Good Documentation Practices :
To lay down the procedure for Good Documentation Practices in the facility.
This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of the Pharmaceutical Company.
All employees of Quality Assurance, Quality Control, Production, Warehouse, Engineering, Personnel & Administration are to follow this SOP.
Department Head & Head QA shall be accountable for the implementation and compliance of this SOP.
Abbreviations and Definitions
SOP: Standard Operating Procedure
GDocP: Good Documentation Practice Good documentation practice
Good documentation Practices shall have the following instruction:
All entries, except IPQA, should be made with blue ball pen in clear and legible handwriting.
All entries by IPQA shall be done in a black ball pen.
Usage of ink pens, gel pens, white out, blade, erasers, flair pens and pencils shall be strictly avoided.
Entries shall be done in clear, visible & legible writing.
Short terms shall be avoided to the maximum extent if not separate abbreviations narrating the short forms shall be provided at the end of the document.
Data recording shall be done online as the work is performed.
The person executed shall sign along with date in relevant documents.
If correction is to be done in any of the documents then strike with single line in such a manner that the original data must remain clear, visible and legible and no information should be obscured by any means.
The correct data is to be written next to (wherever the suitable space will be available), above or below & incorrect the data along with initials, date & a brief explanation of the reason for change.
For writing reason for the correction following abbreviations shall be used for the various type of mistakes e.g. TY: For typographical error, TE: For transfer error, CE: For calculation error & SUP: For Supplementation, as example shown below: Bacth Batch.
Overwriting in document shall be strictly prohibited.
Wherever more than one option is available, tick (√) the options which are applicable.
Wherever issued document requires the entry of additional data, information which is not provided in the document, the same should be handwritten legibly and should be signed with date by the personnel making the entry.
Supplements or any other printout attached to records should be signed with date.
All the columns of the document should be filled. If any column of the document does not require an entry, mention “NA” (Not Applicable) or a line diagonally across the page from left top to right bottom, put “NA” with a signature and date at the bottom.
If a process is not performed or is not applicable in a page, Empty fields must be invalidated by crossing them out, it should be indicated by writing “NA” (Not Applicable ) and diagonal line across the page, with a signature and date at the bottom.
If an observation / recording is found OK / acceptable, the same should be indicated with a tick mark. Wherever legends are used, the same should be specified at the bottom of the document.
Reason / Remark should be entered in the record for any significant cancellations.
If any observations / signature / date to be repeated, the same should be rewritten. Ditto (—-“—-) marking should not be used.
For each activity, signature for operation done by and checked by should be done.
Where logbooks are used in place of loose formats for recording, each page of the logbook should be numbered.
Date shall be written in the form either DD/MM/YY or DD/MM/YYYY, Where DD represents date, MM represents month; MMM represents first three alphabets of month and YY represents last two digits of the year or YYYY represent the year 2023 For example 15/08/23 or 15/08/2023.
Time entries shall be written in the form of 24:00 hrs.
Document entries should be done by the responsible person for that operation.
Document entries made using carbon should be legible and clear.
Do not reuse scrap paper or sheets for recording any data.
Formats having space constraints can be adjusted through file Note to increase the space for recording without disturbing the existing procedure or contents.
This file note shall be enclosed with Master SOP and copy of file note shall be enclosed with recording format by user department.
If any document/ page has to be change due to legibility, wrong entry purpose, it shall be reissued as “DUPLICATE” and the original page shall be retained along with it in the original document with the file note that this document has “duplicate page”.
Forms and Records (Annexures):
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering.
Reason for Revision