by 1.0 PURPOSE:
The purpose of this SOP is to describe the procedure of Vendor Approval for all the vendor who supplies materials, machine parts and services.
2.0 SCOPE:
The scope of this SOP is applicable for all Vendors Process .
3.0 RESPONSBILITY:
- All Staff
- Prepare SOP as required
- Follow SOP as written
- Review content as appropriate
- Department Head
- Ensure the required SOPs are prepared and revised for their department
- Ensure employees in their department are trained on new and revised SOPs as required
- Review SOPs
- QA Chemist/ Officer/ Executive
- Assign the identification code for SOPs
- Circulate and track SOPs for review and approval
- Distribute, update and control SOPs
- Maintain a Master list of SOPs
- Head- Quality Assurance
- Approve the prepared/ update SOPs
- Ensure the compliance of Standard Operating Procedure
4.0 PROCEDURE:
A need for preparation of the new SOP or the revision of the existing SOP is to be Initiated by Officer/Executive/ Department Head.
4.1 Preparation of Draft SOP:
A Draft SOP for their respective department is prepared and reviewed by respective team members and department Head.
- SOPs shall
be prepared in Microsoft Word.
- All SOPs shall be written in English language, which is clear, instructive & sequential.
- All SOPs shall be printed on A4 size white paper in black ink. All SOPs shall have a common header. The text conforms to the following guidelines
| Language | English |
| Font size ( Header/ Footer/Text) | 12 point |
| Font type ( Header/ Footer/Text) | Times New Roman |
| Printing | One side |
- Text shall be divided into logical sections numbered 1, 2, 3 etc. where it relates to
- Purpose
- Scope
- Responsibility
- Procedure
- Distribution
- Annexure
- Reference etc.
The section shall be sub-divided into logical section. 1.1, 1.2, 1.3 etc.
Each SOP shall be allocated unique SOP number by Quality Assurance having alphanumerical system in the form of XXX/YY/ZNNN.
- The first three characters (XXX) denoting the company name.
- Next one character is slash.
- The next two characters (YY) shall be department code for which SOP is written.
- Next one character (/) slash. Next two characters (Z) denoting the category of SOP (i.e. general, calibration, Instrument, Validation, Testing etc.)
- The next three digits (NNN) denoting SOP sequence number starting from 001.
- Finalization of SOPAfter completion of the overall review, the SOP will be signed by following:
- Prepared By :Initiator
- Checked By: HOD
- Approved By: Head QA
- The duly
signed original copy of SOP will be stamped as “MASTER COPY” (Red in
color) on each page in right side of the footer area by Quality Assurance
Officer/ Chemist.
- QA document cell, as a custodian will retain this “MASTER COPY”.
- QA Executive/ Officer shall write the effective date and review date of respective SOP. The review date of all the SOPs shall of three years from the effective date. The original copy (signed in blue ink) of the respective SOP shall be retain by documentation cell as master copy.
- QA Chemist/ Officer shall organize for photocopies for distribution and shall put stamp “CONTROL COPY”,SOPs required for other than distribution list shall be stamped as “UNCONTROLLED COPY” on each page of the bottom of the SOPs in blue ink.Control, issue and retrieval of all the SOPs shall be done by QA Executive/Officer.The approved SOP shall be effective after training of concerned personnel.QA Officer/Chemist shall record the retrieved copy & destroyed. Than put a stamped “SUPERSEDED” in red ink on footer of each page of the master copy. Sign/Date on each page of SOP in green ink for distribution and sign in blue ink.
5.0 DISTRIBUTION:
Master copy : QA department
Control Copy : All departments
6.0 REFERENCE:
In-house
7.0 ABBREVIATIONS:
| SOP | Standard operating procedure |
| G | General |
| QA | Quality Assurance |
8.0 CODE FOR DEPARTMENTS:
| Quality assurance | QA |
| Quality control | QC |
| Maintenance | MN |
| Human resource development | HR |
| IT | IT |
| Account | AC |
| Purchase | PH |
| Soft gel | SG |
| Hard gel | HD |
| Tablet | TB |
| Capsule | CP |
| Syrup | SY |
| Production department common | PD |
| Store | ST |
The following codes shall be used to represent various categories of SOPs:
| CATEGORY | CODE |
| General | G |
| Operational | O |
| Calibration | C |
| Validation | V |
| Testing procedure | T |
| Instrument | I |
