sop for Preparation of validation master plan
1.0 OBJECTIVE :
1.1 To lay down a procedure for preparation of validation master plan.
2.0 SCOPE :
2.1 This procedure is applicable for preparation of validation master plan.
3.0 RESPONSIBILITY :
3.1 Officer / Executive QA or designee shall be responsible for:
3.1.1 Preparation, Controlling, distributing and withdrawal of this SOP.
3.2 Executive/Manager QA shall be responsible for review and revision of this SOP.
3.3 Head QA or designee shall be responsible for approval of this SOP.
3.4 Head QA or designee shall be responsible for ensuring that this SOP is implemented as per laid down procedure.
4.0 ACCOUNTABILITY:
Head QA .
5.0 PROCEDURE :
5.1 VMP shall be prepared with the following header.
|
Company name
|
VALIDATION MASTER PLAN | |
| Document No.: | Supercede No.: | |
| Review period: | Effective date : | |
5.2 Cover page of VMP shall be numbered as 1 and the details of header shall come in the middle of the page.
5.3 Second page of VMP shall be of prepared as mentioned below.
5.3.1 This validation master plan is prepared by
| Department | Quality Assurance |
| Signature | |
| Name | |
| Designation | |
| Date |
5.3.2 This validation master plan is reviewed by
| Department | Quality Assurance | Quality Control | Production | Engineering |
| Signature | ||||
| Name | ||||
| Designation | ||||
| Date |
5.3.3 This validation master plan is approved by
| Signature | |
| Name | |
| Designation | |
| Date |
5.4 Third page of VMP shall have table of content as mentioned below.
| Sr. No. | Content | Page No. |
| 1.0 | Approval of validation master plan (VMP) | |
| 2.0 | Table of content | |
| 3.0 | Introduction | |
| 4.0 | Concept of qualification /Validation | |
| 5.0 | Elements of qualification | |
| 6.0 | Elements of Validation | |
| 7.0 | Requalification / Revalidation | |
| 8.0 | Change control system | |
| 9.0 | Documentation | |
| 10.0 | Other cGMP programs | |
| 11.0 | Reference | |
| 12.0 | Glossary | |
| 13.0 | Performance qualification (PQ) |
5.5 Numbering of the VMP shall be done as follow
5.5.1 For example yyy / VMP-00
5.5.2 yyy = Stands for “ 1 ” which represent company name
5.5.3 VMP = Stands for “ VMP “ that is Validation Master plan.
5.5.4 ZZ = Stands for version number of VMP which starts with 00 and ends at 99. When the VMP is prepared for the first time,
this number starts with 00 and at every revision it will be added up with one number.
5.6 Revision of the VMP shall be done in the following case
5.6.1 Revision of the VMP shall be done in two year routinely.
5.6.2 Revision of the VMP shall be done as per regulatory requirement.
5.6.3 Revision of the VMP shall be done when there is change in facility layouts, change in validation frequency.
6.0 ABBREVIATION :
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | SOP | Standard Operating Procedure |
| 2.0 | VMP | Validation Master plan |
| 3.0 | QA. | Quality Assurance |
7.0 REFERENCE :
| Sr. No. | Reference Title |
| 1 | PIC/S- Validation Master Plan (Pharmaceutical Inspection Co-operation Scheme) |