SOP on writing & approval of Qualification and validation protocol & reports

SOP on writing & approval of Qualification and validation protocol & reports

Objective:

To describe the procedure for writing & approval of qualification and validation protocols & reports.

Scope:

This SOP is applicable to all type of qualification and validation protocol & report for all department to Formulation plant of pharmaceutical Company.

Responsibility:

The officer / executive / section in-charge who initiates the operation or activity of the department.

Accountability:

Head –QA shall be accountable for compliance of this SOP.

Procedure:

1.Periodic Validation:

  • All type of validation protocol should be on A4 size paper. The protocol should be written with font type Times New Roman only and font size 11.
  • Cover page of protocol:
  • The cover page of the protocol shall consist of the equipment name and equipment Id or area where activity performed.
  • There is double space between them and the font type is in Times New roman and font size is 20.
  • Header
  • Header must be on each & every page of the protocol & report as per details given below for:
  • The header of validation protocol shall consist of the following :
Company Logo Company Name Protocol No. PR/VL/AA/BB/CC
Equipment No.
Effective Date DD-MM-YYYY
Validation Protocol Page X of Y
Equipment Name:
  • Protocol No. be written in format PR/VL/AA/BB/CC and report No. should be written in format RP/VL/AA/BB/CC,
  • PR refers for Protocol and RP refers for report, VL refers to validation, AA refers to type of study performed BB refers to Number of the Protocol and CC refers to revision no. of the protocol. Revision no. of the protocol shall be done with proper change control procedure refer SOP on change control procedure SOP.
  • Protocol numbering shall be done as per SOP on document numbering.
Company Logo Company Name Report  No.   RT/VL/XX/01/YY
Equipment No.
  Validation report Page X of Y
Equipment name:
  • The header for validation report
  • The company name  should be at center in capital, bold letters with font type Times New Roman font size 11.
  • The page no. shall be written in right side corner in front of validation protocol/validation report  with font type Times New Roman with font size 11.

2. Validation Protocol (General Content)

  • Header
  • Header must be on each & every page of the protocol & report as per details given below for:
  • The header consists of the following :
Company Logo Company Name Protocol No. PR/AA/BB/CC
Market
TYPE OF VALIDATION PROTOCOL Effective Date
Page X of Y
Product Name Product Name

Protocol No. for should be written in format PR/ AA/BB/CC and report No. should be written in format RP /AA/BB/CC,

PR refers for Protocol and RP refers for report, AA refers to type of study , BB refers to Number of the Protocol and CC refers to revision no. of the protocol. Revision No. of the protocol go through the proper change control procedure refer SOP on change control procedure SOP.For details of Protocol No. SOP on document numbering.

The company name should at centre in capital & bold letters with font type Times New Roman font size 11.

The page no. shall be placed at the bottom right corner in front of validation protocol with font type Times New Roman with font size 11.

Table of contents:

The title ‘TABLE OF CONTENTS’ shall be written in with font type Times New Roman font size 11.

The following below minimum table of contents for process validation, but not limited to shall be covered.

  • Description
  • Protocol approval
  • Overview
  • Objective
  • Purpose
  • Scope
  • Responsibility and Validation team
  • Training
  • System Description
  • Validation Test Procedures
  • Discrepancy and corrective action report
  • References
  • Summary
  • Conclusions
  • Appendix
  • Periodic Validation Criteria
  • Revision History
  • Body of protocol / report:
    • The line spacing between Heading / Subheading / note = single.
    • The heading, sub-heading and note shall be in bold letter.
    • The text body of protocol or report shall be written with font type Times New Roman and size 11 including bullets and numbering also.
    • Paragraph spacing (before & after) = 6 pt.
    • The numbering indent from left = 0 inch & the hanging indent / left tab 0.5”
    • For example the details of body text are given below:
  • Protocol Approval :

In the approval sheet of the protocol/Report, representative of following departments shall do the  signing:-

Signing of this approval page of protocol indicates agreement with the validation approach described in this document. If any modification in the equipment validation approach becomes necessary, a revision through change control shall be prepared, checked and approved. This protocol cannot be executed unless approved by following personnel.

Protocol writing with respect to activity:

Overview

To establish the methodology to provide documentary evidence w.r.t. activity in details of specification, component & features etc.

Objective

The objective of the protocol i.e. procedure and plan for validation on the Equipment with Equipment ID is defined.

Purpose

The purpose of this Protocol for which the validation is carried out shall be defined .

Scope

The scope of the protocol is limited to for which validation and where the validation is performed shall defined.

Responsibility and Validation Team: – In this section responsibilities of various departments during validation activity shall be defined.

Training: Training shall be conducted formally by concern expert or QA person which involve in the validation activity and she / he must have knowledge of that activity. Training record shall be attached with validation report.

Equipment /System Description: – In this section equipment make, model, capacity, location, dimensions and there working principle and design specification shall be defined.

Validation procedure: Under this detail procedure of the validation shall be mentioned that what are the actives shall be done in the validation and what is the testing procedure, acceptance criteria and recording of the result.

Pre- Validation Requirements: in this section what are the requirements to be completed prior to validation activity shall be defined.

Discrepancy and corrective action report: Under this section if any Discrepancy is observed during the validation shall be reported and corrective action must be documented and it must be verified by the department Head and QA head.

References

All the references which are prefer during the validation activity for the preparation for the protocol and testing procedure must be documented in the validation protocol not in the report.

Summary

The validation summary report shall include Protocol reference , Dates of validation activities, Pre-validation testes performed, Confirmation of calibration and preventive maintenance,  and result obtained and acceptance criteria .

Conclusion

The validation report shall include statement for conclusion of the validation activity based on result and observation from the validation activity.

Appendix

All the attachments such as test data sheet with S.No. Title and No. of pages must be mention in the form of Tables. It mention in the protocol not in the report

Abbreviation used are must be mention with abbreviation and there definition

Periodic Validation Criteria

The periodic and revalidation criteria are mention in the protocol with the name of test and frequency.

Revision History

In the revision history for which the protocol is revised is mention.

Installation qualification /operational qualification and Performance qualification Protocol cum Report :

All type of validation protocol cum report should be on A4 size paper. The protocol should be written with font type Times New Roman only and font size 11.

Cover page

The cover page should consist of following content which shall be written in font size of 20 with Times new Roman of font type  bold in capital letter. This format shall be used where one time validation is required.

In this page following content shall be mentioned:

Type of qualification i.e. Installation qualification, operational qualification or performance qualification.

Equipment Name and equipment ID.

 Header

The header should consist of the following contents. For example:

Company logo Company Name  Page X of Y
INSTALLATION  QUALIFICATION PROTOCOL CUM REPORT
Equipment name
Protocol cum Report No. PRCR/IQ/EQ.ID/XX/YY Effective Date DD-MM-YYYY

The details of Header content shall be written in font theme of Times New Roman and font size  of 11 .

The Protocol Cum Report No. shall be written in format PRCR/Type of Qualification/Equipment ID/Number of the Protocol/revision no. of the protocol.

For installation qualification write IQ, for operational qualification write OQ, for performance qualification write PQ, for operational cum performance qualification refer OQ-PQ.

Table of contents for Installation Qualification:

The title ‘TABLE OF CONTENTS ‘shall be written in font theme of Times New Roman   with font size of 11.

The following minimum table of contents but not limited to shall be covered .

Contents

  • Pre Approval
  • Overview
  • Purpose
  • Responsibility
  • Re-qualification
  • Equipment Description
  • Equipment Specification
  • Equipment Identification
  • Equipment Location
  • Installation Qualification Procedure
    1. Inspection Checklist
    2. Installation Qualification
    2.1. Major Component Verification
    2.2.  Material Of Construction Verification Checklist
    2.3. Verification of utility supply
    2.4. Critical instrument list with calibration requirements
    2.5. Verification of Installation
    2.6. Levelling and Alignment
    2.7. Drawing & Manual
    2.8. Deviation (if any) and corrective Action
  • Acceptance criteria
  • Remarks (If Any)
  • Summary
  • Appendix
  • Post Approval Signature
  • Approval Page: For Installation Qualification /Operational Qualification and Performance Protocol cum Report following department shall review the document:
    • Pre Approval
    • Signing of this approval page of protocol cum report indicates agreement with the qualification approach described in this document. If any modification in the equipment qualification approach becomes necessary, a revision through change control shall be prepared, checked and approved. This protocol cannot be executed unless approved by following personnel.

Overview: To establish the methodology to provide documentary evidence with respect to activity in details of specification, component & features etc.

Purpose – The purpose of the protocol to provide an outline for the Installation Qualification static attributes

Responsibility:- It consists of Responsibilities of various department in the qualification

Requalification: – It consists of requalification of the equipment.

Equipment Description:- It consists of purpose of the equipment ,Basic mode of operation ,GMP feature ,major component verification, ,capacity ,location ,dimensions.

Equipment specification: Under this specification of the machine shall be defined

Equipment Identification: Under this equipment ID, make, capacity, Name of the supplier, purchase order and date shall be mentioned.

Equipment Location : Under this facility, floor, Area, Room Name room ID shall be mentioned

Installation Qualification procedure : Under this Inspection check list, major component verification with make, model capacity dimension material of construction is defined ,LCD or control Panel or HMI keys display must be defined , Material of construction verification ,verification of Utility supply, i.e. electrical supply, Compressed air, water ,Critical instrument with calibration check list ,location assembly, leveling of the equipment ,Installation Verification, Drawing and manuals,

Deficiency (if any) and corrective action report: Under this section the Deficiency if any shall be reported.

Acceptance criteria: under this section check the acceptance criteria for installation

Summary: under this section summarized all the installation qualification activity.

Conclusion: under this section give the result of all the qualification activity and data that should be mentions that it under goes for operational qualification activity.

Post approval signatures: after the installation qualification all the data reviewed by the head of the engineering, production and quality head and take the certification of its approval.

Appendix : Under this section mention the abbreviation and list of the document

 

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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