Establishing Standard Operating Procedures Good Data and Record Management Practices (SOP for SOPs) also known as Good Documentation Practices (GDocP), is crucial in maintaining a high standard of data and record management within an organization. The following is a template outline for an SOP for SOPs, emphasizing good data and record management practices.

PURPOSE

• All the Quality Management System and Good Manufacturing Practices (GMP) documents are prepared, properly reviewed and approved by appropriate authorities prior to issue or available at the appropriate locations.
• All Quality System records related to Quality Management System and GMP are properly identified, filed, indexed, stored, retained and disposed of. Distribution / Circulation/Retrieval Implementation Control.

SCOPE

• This procedure applies to all the documentation and records related to Quality Management System (QMS) and GMP. EMS / EHS SOPs.
• This document complies with WHO and PNAC (Pakistan National Accreditation Council) ISO/IEC 23025:2023(E) standard.

ROLES & RESPONSIBILITIES

PROCEDURE

Good Data and Record Management Practices (SOP for SOPs)

Guideline for writing SOP

1. Documents should be designed, prepared, reviewed and distributed with care. They should comply with the relevant parts of the manufacturing.
2. Documents should accurately reflect the current methods used within the plant and within the department to ensure that premises, equipment, and processes comply with GMP requirements.
3. Responsibility for each function should be clearly defined.
4. Documents should be approved, signed and dated by the appropriate responsible persons. author, reviewer, Approver and Authorizer must be trained on relevant policies.
5. Where applicable, equipment, time format ( shall be mentioned in AM and PM), frequency, documentation, physical parameters, control and cross reference should be clearly specified
6. If abbreviations are used then glossary should be given.
7. HSE aspects and international guidelines should also be considered where applicable.
8. Effective date should be allotted after training of relevant standard operating procedure it should be within 7 days after issuance.
9. No document should be changed without authorization and approval.
10. Documents should have unambiguous contents: the title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
11. Where documents require the entry of data, these entries should be clear, legible and indelible. Enough space should be provided for such entries. All work performed is recorded legibly. Work is recorded in such a manner that another individual, competent in the same field, may repeat the work described solely from the description written without additional explanation.
12. Entries contain the date, initials of person performing the work, signed and dated.
13. Entries are made in ink. No erases are made. Blank space will be indicated with a line. Lead pencils are not used.
14. Corrections will be made by drawing a single line through the incorrect entry, enter the correct information, initial and date the change.
15. Data may be recorded electronically. If documentation is handled electronically, only authorized persons should be able to enter or modify the data in the computer system and there should be a record of changes and deletions. Access should be restricted by passwords or other means and the entry of critical data should be independently checked. It is particularly important that during the period of retention, the data is readily available.
16. Electronic record and data files are backed up on a regular basis to safeguard against the loss of information due to equipment malfunction or human error.
17. Data will be backed up on daily, weekly, monthly and annual basis.
18. External surfaces of disk and diskettes CDs or DVDs are labeled to facilitate accurate filing and retrieval of electronic records. Examples of information may be included on the label are:
19. Subject or functional title which identifies the information.
20. Inclusive dates of information contained on the diskettes, CDs or DVDs, and identification of the software program used to access the information.
21. QA and IT department will retain HPLC backup in hard drive.

SOP Layout Design\Format

1. Header of page
2. Department Name
3. SOP Title
4. Issue Date: Issue date is the Authorized date of SOP and must be mentioned in DD-MM-YYYY
5. Effective Date: Effective date is the training date of relevant SOP and must be mentioned in DD-MM-YYYY
6. Review Date: two years from the month of preparation of SOP or before three years if changes necessitated.
7. Supersedes: Revision number of same original SOP that is effective till date. Original SOP should be submitted to Quality Assurance Manager and Copies to list attached at the end of SOP.
8. Signature Lines along with name, date and designation (Prepared by, Reviewed by, Approved by, Authorized by) in blue ink.
9. There should be a statement in a text box on header of SOP where the text is: “All the SOPs shall be treated confidential and shall not be shown to un-authorized persons”.
10. No two signatures on a signal document can be made by same person. (Unless justified).

Sop Number Allocation

1. Each SOP will have a specific number. The number is assigned in a following manner;
2. Department Code
3. Section Coding
4. Subject: