SOP

1. Objective
To lay down a procedure for preparation of policy documents and numbering of qualification and validation documents.

2. Scope
The SOP is applicable for policy documents related to quality Management systems and also provides guideline for numbering of validation protocols and reports.

3. Responsibility
Quality Assurance Department
4. Procedure
4.1 The in-house policy documents are Quality policy, Quality manual, Validation master plan, Site master file, site organogram and safety policy. All policy shall be numbered as PS/POL/NN; where PS is PharmaState, POL is policy and NN is chronological number starting with 01
4.1.1 Quality Policy:
Shall bear the number 01.
It shall be drafted and signed by the head of the organization.
4.1.2 Quality Manual
Shall bear the number 02
Shall be prepared Head of QA and authorized by Head of QA and Head of the organization.
4.1.3 Site organogram
Shall bear number 03
shall be prepared by human resource department and shall be authorized by Head of the organization.
4.1.4 Roles & Responsibilities
Shall bear number 04
shall be prepared by human resource department and shall be authorized by Head of the organization.
4.1.5 Validation Master Plan
shall bear number 05
shall be prepared by validation team member and approved by QA head.
4.1.6 Site Master File
Shall bear number 06
shall be prepared by designated quality assurance person and approved by factory head and QA head.
4.1.7 Safety policy
Shall bear number 07
shall be prepared by designated person from engineering and approved by QA head.
4.1.8 Company Policy
Shall bear number 08
shall be prepared by human resource department and shall be authorized by Head of the organization.
4.1.9 Management of the policy documents
Organogram, site master file and validation master plan are the live documents and are to be maintained updated with the current status. Annexures attached to these policy documents shall be replaced as when required to maintain the current updated document. The change of the annexures shall be through change control procedure. The master document is to be revised only when the text in the main document is required to be changed.
Validation Master plan shall be maintained only in QA and the validation team shall refer the document as and when needed.
The photocopies of the other policy document shall be distributed to concerned departments.
The policy documents shall be revised at least once in 3 years.

4.2 Validation Documents
4.2.1 Cleaning Validation
Protocol: Cleaning Validation Protocol shall be numbered as CVP/Equipment ID/Name of Product/ NNN; NNN is chronological number starting from 001.
Report: Cleaning Validation Report shall be numbered as CVR/Equipment ID/Name of Product/NNN, NNN is chronological number starting from 001.
4.2.2 Process Validation:
Protocol: Process Validation Protocol shall be numbered as PVP/Product code/B. Size/ Version no.
Report: Process Validation Report shall be numbered as PVR/ Product code/B. Size/ Version No.

4.2.3 Analytical method validation
Analytical method validation Protocol and Report shall be numbered as AD/MV/Product code/NNN where NNN is a chronological number specific for each method viz. 001 for assay, 002 for Dissolution, 003 for related substances, etc.
For Cleaning validation: Analytical Validation Protocol and Report shall be numbered as AD/CV/Product code/NNN

4.2.4 Experimental Validation
Protocol: Experimental Protocol shall be numbered as EXP/DD/YY/NNN; where DD is department, YY is last two digit of current year and NNN is chronological number starting from 001.
Report: Report shall be numbered as EXR/DD/YY/NNN

4.3 Revalidation: In case of revalidation, the protocol and report numbering shall remain the same.
For protocol, only revision number shall be changed. Report shall show the reference protocol number and its revision number.

4.4 Numbering system for User Specification 
User specifications for facility shall be numbered as URS/NN/YY/ NNN where NN is category viz. 01 for facility, YY is last two digits of year of URS and NNN is serial chronological number starting from 001.
User specifications of Utility services and Equipment / Instruments shall be numbered as URS/DD-NN/YY/NNN, where DD is department, NN is 02 for Utility services and 03 for Equipment / Instruments.
For each category (NN), the chronological number (NNN) shall start from 001.

4.5 Equipment or Instrument Qualification
4.5.1 Protocol: Equipment or Instrument Qualification Protocol shall be numbered as XQP/Equipment or Instrument No.; where X is category of qualification viz. I for Installation Qualification, O for Operational Qualification and P for Performance Qualification.
4.5.2 Report: Qualification report shall be numbered as XQR/Equipment or Instrument number.
4.5.3 Design Qualification document of Equipment or Instrument shall be numbered as DQ/Equipment or Instrument No.
4.5.4 For Design Qualification of a system which comprise of two or more equipment numbers, the Design Qualification document shall be numbered as DQ/Name of system.
4.5.5 For the equipment which are not previously qualified, a comprehensive qualification protocol can be prepared which covers installation, operational and performance parameters as applicable. The protocol and report shall be numbered as QP/Equipment No. and QR/Equipment No. respectively.
4.6 Facility Qualification:
4.6.1 Design Qualification document for facility shall be numbered as DQ/Facility/NN; where NN is category viz. 01 for Factory and 02 for ADL.
4.6.2 Protocol: Facility Qualification Protocol shall be numbered as QP/Facility/NN.
4.6.3 Reports: Facility Qualification Report shall be numbered as QR/Facility/nn.

4.7 Re-qualification
4.7.1 In case of re-qualification of equipment, the protocol and report shall be numbered as RQP/Equipment and RQR/Equipment No. respectively.
4.7.2 In case of Re-qualification of facility, the protocol and report shall be numbered as RQP/Facility/NN and RQR/Facility/NN respectively.
4.7.3 Report shall bear clearly the guideline protocol number and its revision number in order to avoid the confusion.
4.7.4 Numbering for all qualification and validation documents shall be assigned by QA. A comprehensive list shall be maintained in QA

5. Abbreviations
SOP: Standard operating procedure
QA: Quality assurance

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