Objective of Good Documentation Practices :

To lay down the procedure for Good Documentation Practices in the facility.

Scope: This standard operating procedure applies to all departments involved in documentation activities throughout the facility of the Pharmaceutical Company.

Responsibility: All employees of Quality Assurance, Quality Control, Production, Warehouse, Engineering, Personnel, and administration must follow this SOP. 

Accountability: The Department Head & Head QA shall be accountable for the implementation and compliance of this SOP.

Abbreviations and Definitions

SOP: Standard Operating Procedure

GDP: Good Documentation Practice

Procedure: Good documentation Practices shall have the following instructions:

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.

Using ink pens, gel pens, white, blades, 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 no separate abbreviations narrating the short forms are 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 the date in relevant documents.

If correction is to be done in any of the documents then strike with a single line so 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 the change.

For writing the reason for the correction following abbreviations shall be used for the various types 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 documents shall be strictly prohibited.

Wherever more than one option is available, tick (√) the applicable options.

Wherever the issued document requires the entry of additional data or information that is not provided in the document, the same should be handwritten legibly and should be signed with a date by the personnel making the entry.

Supplements or any other printout attached to records should be signed with a 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 on a page, Empty fields must be invalidated by crossing them out, it should be indicated by writing “NA” (Not Applicable ) and a 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/signatures/dates are to be repeated, the same should be rewritten. Ditto (—-“—-) marking should not be used.

For each activity, a signature for the 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.

The date shall be written in the form either DD/MM/YY or DD/MM/YYYY, Where DD represents the date, MM represents the month; MMM represents the first three alphabets of the month and YY represents the last two digits of the year or YYYY represents the year 2024, For example, 15/02/24 or 15/02/2024.

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 a copy of the file note shall be enclosed in recording format by the user department.

If any document/ page has to be changed due to legibility, or 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”.

SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM

Forms and Records (Annexures):

Not applicable.

Distribution

• • Master copy – Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering.

SOP for Product Process Qualification(PPQ) /Process Validation in Pharma