SOP for Quality Management Documents Numbering System

Objective

To lay down a procedure for the preparation and numbering of quality management documents.

Scope

• The SOP is applicable for documents related to quality Management systems and also provides guidelines for the numbering of validation protocols and reports.
• This procedure applies to:

1. Process Qualification protocol and report (SOP- Process Qualification)
2. Hold time study protocol and report
3. Cleaning validation protocol and report
4. Equipment qualification protocol
5. Protocol for other activities
6. Addendum/ Supplement to an approved protocol

Responsibility

• The Quality Assurance Department and Quality Control Department allot the number of each and maintain the record of numbering and issue working copies of the approved to the user department.
• Regulatory Affairs or designee, Quality Head, and plant Head review and approve the SOP.
• Maintenance Dept. shall be responsible for preventive maintenance and calibration of equipment and instruments respectively.
• QA Head shall review & approve process qualification protocol & report for its completeness and correctness concerning all data and reports and ensure implementation of SOP.

Procedure

• The in-house policy documents are Quality policy, Quality manual, Validation master plan, Site master file, site organogram, and safety policy. All policies shall be numbered as 

PS/POL/NN; 

Where,

PI: PharmaInfo

POL: policy 

NN: chronological number starting with 01

Quality Policy

• Shall bear the number 01.
• It shall be drafted and signed by the head of the organization.

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Quality Manual

• Shall bear the number 02
• Shall be prepared Head of QA and authorized by the Head of QA and Head of the organization.

Site organogram

• Shall bear number 03
• shall be prepared by the human resource department and shall be authorized by the Head of the organization.

Roles & Responsibilities

• Shall bear number 04
• shall be prepared by the human resource department and shall be authorized by the Head of the organization.

Validation Master Plan

• shall bear number 05
• shall be prepared by validation team members and approved by the QA head.

Site Master File

• Shall bear number 06
• shall be prepared by a designated quality assurance person and approved by the factory head and head.

Safety policy

• Shall bear number 07
• shall be prepared by a designated person from engineering and approved by the QA head.

Company Policy

• Shall bear number 08
• shall be prepared by the human resource department and shall be authorized by the Head of the organization.

Management of the policy documents

• Organogram, site master file, and validation master plan are the live documents and are to be maintained and updated with the current status. Annexures attached to these policy documents shall be replaced when required to maintain the current updated document. The change of the annexures shall be through a change control procedure. The master document is to be revised only when the text in the main document is required to be changed.
• The validation Master plan shall be maintained only in QA and the validation team shall refer to the document as and when needed.
• The photocopies of the other policy documents shall be distributed to the concerned departments.
• The policy documents shall be revised at least once in 2 years.

Validation Documents

Cleaning Validation

Protocol:

• Cleaning Validation Protocol shall be numbered as CVP/Equipment ID/Name of Product/ NNN; NNN is a chronological number starting from 001.

Report:

• Cleaning Validation Report shall be numbered as CVR/Equipment ID/Name of Product/NNN, NNN is a chronological number starting from 001.

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.

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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.

Cleaning validation:

• Analytical Validation Protocol and Report shall be numbered as AD/CV/Product code/NNN

Experimental Validation:

Protocol:

• Experimental Protocol shall be numbered as EXP/DD/YY/NNN; where DD is a department, YY is the last two digits of the current year and NNN is a chronological number starting from 001.

Report:

• The report shall be numbered as EXR/DD/YY/NNN

Revalidation:

• In case of revalidation, the protocol and report numbering shall remain the same.
• For protocol, only the revision number shall be changed. The report shall show the reference protocol number and its revision number.

The numbering system for User Specification

• User specifications for the facility shall be numbered as 

URS/NN/YY/NNN 

where 

NN: category viz. 01 for facility, 

YY: last two digits of the year of URS

NNN: 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: department, 

NN: 02 for Utility services and 03 for Equipment / Instruments.

For each category (NN), the chronological number (NNN) shall start from 001.

Equipment or Instrument Qualification

Protocol:

• Equipment or Instrument Qualification Protocol shall be numbered as XQP/Equipment or Instrument No.; where X is a category of qualification viz. I for Installation Qualification, O for Operational Qualification, and P for Performance Qualification.

Report:

• Qualification report shall be numbered as XQR/Equipment or Instrument number.
• Design Qualification document of Equipment or Instrument shall be numbered as DQ/Equipment or Instrument No.
• For the Design Qualification of a system that comprises two or more equipment numbers, the Design Qualification document shall be numbered as DQ/Name of the system.
• For the equipment that is not previously qualified, a comprehensive qualification protocol can be prepared that covers installation, operational, and performance parameters as applicable. The protocol and report shall be numbered as QP/Equipment No. and QR/Equipment No. respectively.

Facility Qualification:

• Design Qualification document for the facility shall be numbered as DQ/Facility/NN; where NN is category viz. 01 for Factory and 02 for ADL.
• Protocol: Facility Qualification Protocol shall be numbered as QP/Facility/NN.
• Reports: Facility Qualification Report shall be numbered as QR/Facility/NN.

Re-qualification

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

A numbering system for other protocols:

• The Numbering system for any other activity shall be done as per steps.
• An abbreviated form of activity shall be decided based on the activity being performed.

Addendum/Supplement to approval protocol:

• Any additional activity to be performed apart from the approved protocol shall be addressed as an addendum.
• The number of addendums shall remain the same as that of the approved protocol.
• The number of addendums shall be suffixed by A, B, C, and onward based on no. of addendums.

Issuance system:

• Photocopy of Approved protocols shall be issued to the concerned for collecting the data and treated as a report.
• The working copy of the Approved photocopy shall be authorized by the QA Officer whoever is responsible for the issuance of protocol and report of issuance to be maintained as per 1, 2, 3 & 4
• After completion of collecting data, submit a filled copy with the necessary attachment to the QA Head or Designee.

Abbreviations

SOP: Standard operating procedure

QA: Quality assurance

Annexure

Nil

Revision History

Nil

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