sop for numbering and approval of formats
1.0. OBJECTIVE:
The objective of this SOP is:
1.1 To describe procedure for approval and numbering of Formats.
2.0. RESPONSIBILITY:
2.1 Head of the respective Department shall be:
2.1.1. Responsible for preparing the format as per their requirement.
2.1.2. Responsible for taking approval of Quality Assurance.
2.2 Quality Assurance shall be:
2.2.1 Responsible for checking and approving the format.
2.2.2 Responsible for giving the Format Number.
3.0. ACCOUNTABILITY:
Head – Quality Assurance
4.0. PROCEDURE:
4.1 The guideline used in this SOP encompasses all Formats used across the Plant except Engineering services Department.
4.1.1 All formats used shall have unique reference number, which shall identify that Format. The Format shall have a cross reference to any superseded Format.
4.1.2 Format shall be prepared by concerned department and sent to QA Manager (in duplicate) for Approval and allocation of Format No.
4.1.3 The Format No. shall consist of 17 characters and shall be placed in left side corner of Footer preferably in Font size of 10 & Bold letters.
4.1.4 First & Second Character signifies Department code (Annexure – 1).
4.1.5 Third Character shall signify slash “ / ”.
4.1.6 Fourth, Fifth & Sixth Character shall signify three digit serial no. starting from 001 showing the Format number.
4.1.7 Seventh Character shall signify dash “ – “.
4.1.8 Eighth & Ninth Character shall signify two digit serial no. starting from 00 showing the current version status of the Format.
4.1.9 Tenth Character shall signify slash “ / ”.
4.1.10 Eleventh & Twelfth Character shall signify two digit serial no. starting from 01 showing the Month of implementation of the Format.
4.1.11 Thirteenth Character shall signify dash “ – “.
4.1.12 Fourteenth, Fifteenth, Sixteenth & Seventeenth Character shall signify four digit serial no. Starting from 2000 showing the year of implementation of the Format. e.g. Format for SOP shall be numbered as QA/001-00/12-2000.
4.1.13 For Engineering: The format numbering system shall include the SOP number to which the format pertains followed by slash ( / ) then followed by F-1 which denotes the first format pertaining to that particular SOP. e.g the format shall be numbered as A/EP/003/F-1
4.1.14 Approval of the Format is done by stamping “APPROVED“ in Green color ink with Signature & Date.
4.1.15 Head – Quality Assurance retains one copy of the Approved Format and returns the second copy to the respective Department after Approval and allocation of Format No.
4.1.16 All the Department shall maintain an updated, consolidated list of all the Formats along with its Format No. being used in the department.
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:
Annexure – 1 : List of Departments with Code.
9.0. REFERENCE:
In-house
ANNEXURE – 1
LIST OF DEPARTMENTS WITH CODE
| Sr. No. |
DEPARTMENT |
DEPARTMENT CODE |
| 1 | Personnel & Administration | PA |
| 2 | Production – Capsule | PC |
| 3 | Production – Injection | PI |
| 4 | Production – Liquid | PL |
| 5 | Production – Tablet | PT |
| 6 | Production – Packaging | PP |
| 7 | Quality Assurance | QA |
| 8 | Warehouse | WH |