standard operating procedure for documentation and data control
1.0. OBJECTIVE:
The objective of this SOP is:
1.1 To describe a procedure on the preparation, revision, and distribution
of necessary documents related to Manufacturing and Quality Control.
2.0. RESPONSIBILITY:
2.1 Head of the respective Department shall be:
2.1.1. Responsible for following the SOP.
2.2 Quality Assurance shall be:
2.2.1 Responsible for ensuring the adherence of SOP.
3.0. ACCOUNTABILITY:
Head – Quality Assurance
4.0. PROCEDURE:
4.1 DOCUMENT CONTROL
4.1.1 The guidelines used in this SOP encompass all documents used in manufacturing & Quality Control.
4.1.2 All master documents used [e.g. Master Formula, Batch, SOPs, Standard Test Procedures, etc.] shall have at least two signatures, out of which one should be of either Quality Assurance Head or Head of the location.
4.1.3 Every such document shall have a unique reference number, which shall identify that document. The document shall have a cross-reference to any superseded document.
4.1.4 All such documents shall be typed/ computer printed/ laser printed or equivalent. No hand written documents shall be considered as Master Documents.
4.1.5 All such documents shall be signed in ink and the person signing these shall put the beneath his signature or in the space designated for the same. All pages of the master documents shall be stamped /printed as “MASTER COPY” in Red on the top right corner of the front side of each page.
4.1.6 Every such document shall have a review period when it shall be mandatorily reviewed.
4.1.7 The circulation of these documents shall be restricted to authorised users only. All pages of the photocopies of Documents shall be stamped as “CERTIFIED COPY” in Blue at the bottom right corner of each page.
4.1.8 No changes in any such documents are allowed by the users. Whenever any changes are necessary in any document, the document shall be revised and given for approval of QA.
4.1.9 The proposed revision shall be initiated by concerned persons after formal approval of proposal, pertaining to respective document by Head QA.
4.1.10 Revised copy shall be printed. The details of revision and reason of revision shall be specified
4.1.11 The revised copy shall be signed by concerned persons who has initiated the document and is checked and approved by HOD and Head Quality Assurance (except of QA, which shall be approved by another QA/QC Executive).
4.1.12 Finally the revised copy shall be authorised by Head of technical operations. All obsolete copies shall be withdrawn by the Quality Assurance Department prior to distribution of revised copy
4.1.13 All superseded and retrieved copies shall be destroyed by the Quality Assurance Department. The Master copy of the superseded document shall be retained by the Quality Assurance Department for reference purpose. The same copy shall be stamped as “OBSOLETE” accordingly to avoid any reissue/reuse.
4.1.14 The changes, which may affect the regulatory filings must be first cleared by the Quality Assurance Department. A cross-reference to the superseded document shall be made in the new document.
4.1.15 It shall be the responsibility of the Quality Assurance Department to issue fresh documents having retrieved all superseded documents.
4.2 Revision of BMR/BPR:
4.2.1 The proposed revision shall be initiated by Production Executive /Quality Assurance Executive. The same shall be reviewed by a committee comprising of Production Head, Quality Assurance Head & Head of the Locations.
4.2.2 The Change Control Proposal shall be sent to R&D along with the revised BMR /BPR
4.2.3 Having found satisfactory evidences of scientific rationale given in support of proposed change , Head R&D approves the Change Control proposal.
4.2.4 The Head R&D shall approve the revised BMR/BPR. Finally the Change control proposal and revised BMR/BPR shall be approved by President (Head – Technical Operations).
4.2.5 The approved hard copy of BMR / BPR shall be treated as MASTER BMR/BPR.
4.3 Revision of Formats:
4.3.1 The proposed revision shall be initiated by concerned Executive / Officer and reviewed and approved by Head of Department.
4.3.2 Finally the proposed formats shall be approved by QA.
4.3.3 The approved formats shall be kept by Quality Assurance by stamping the “MASTER COPY” stamp on the top right side corner.
4.3.4 While issuing these formats to user departments the “QUALITY” Stamp shall be stamped on the left corner of the photocopy of the format.
4.4 Revision of Manuals / Site Master File :
4.4.1 The proposed revision shall be initiated by related functional head & Head QA.
4.4.2 The detail of revision and reason of revision shall be discussed.
4.4.3 The changes which may affect the regulatory filings must be first cleared by the Quality Assurance Department. A cross-reference to the superseded document shall be made in the new document.
4.4.4 It shall be the responsibility of the Head-Quality Assurance to Approve the Site Master File.
4.5 Revision of STPs / Specifications:
4.5.1 The revision of STPs / Specifications shall be initiated by Quality Control / Quality Assurance Executive / Officer to incorporate the changes in revised specification / STPs.
4.5.2 The proposed revision shall be initiated by user Executive / Officer , pertaining to respective STP/ Specifications and approved by Head Quality Assurance and finally by CQA.
4.5.3 Revised copy shall be printed.
4.5.4 Finally the revised copy shall be approved by Head Quality Assurance. All obsolete copies shall be withdrawn by the Quality Assurance Department prior to distribution of revised copy and the record of retrieved copy shall be kept.
4.5.5 All superseded and retrieved copies shall be destroyed by the Quality Assurance Department. The Master copy of the superseded document shall be retained by the Quality Assurance Department for reference purpose. The same copy shall be stamped as “OBSOLETE” to avoid any reissue/reuse.
4.6 DATA CONTROL
4.6.1 All the data maintained in software shall be assessable only to Head of Department and a second person in the Department who is responsible for operation.
4.6.2 Any reprocessing in the data generated by software shall not be allowed..
4.6.3 Any reprocessed data shall be treated as VOID, if consequently valid reason for reprocessing is not given.
4.6.4 Data related to calibration, monitoring and validations shall be authenticated by Head of concerned department.
4.6.5 Unloading of data in hard disc shall be done by system operator and all such disc shall be kept under lock and key with concerned Department. The keys shall be kept with the Dept. Head.
4.6.6 The distribution of data to other than user shall be done only after approval of Departmental Head and Head – Quality Assurance.
4.6.7 The manually observed data shall be recorded by the OPERATOR/ USER on approved formats only.
4.6.8 Automatic calculations and results made by the software shall be validated by the user on a defined frequency
5.0. REASON FOR REVISION:
This SOP is revised due to revision due date.
6.0. TRAINING:
Trainer — Head – Quality Assurance
Trainee — All departmental heads / Quality Assurance Personnel
Period — One day
7.0. DISTRIBUTION:
Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Head of Department – Warehouse
Certified Copy No. 3 : Head of Department – Engineering
Certified Copy No. 4 : Head of Department – Personnel and Administration
Original Copy : Head – QUALITY ASSURANCE
8.0. ANNEXURE:
Nil.
9.0. REFERENCE:
In-house