SOP for Process Validation and Equipment Qualification

OBJECTIVE

To establish the procedure for handling Equipment Qualification and Process Validation samples received in the Quality Control department.

SCOPE

This SOP applies to Equipment Qualification and Process Validation samples received in the Quality Control department.

RESPONSIBILITY

Officer, Executive – Quality Control

Head – Quality Control

PROCEDURE

For Equipment Qualification Batches:

• The Quality Assurance Department will send samples from different stages of various Equipment from different locations, along with a requisition slip as per their sampling plan outlined in the respective Protocol.
• Upon receiving the samples, make the necessary entry in the inward register as per Annexure-I.
• Generate the A.R. number for Equipment Qualification samples using the format: EQ-0001/22

1. EQ: Equipment Qualification
2. 0001: Serial number of the sample
3. 24: Last two digits of the year (2024)

ALSO READ: Why Three Batches are Taken for Validation?

• Write the A.R. number on the requisition slip received with the samples from the QA Department.
• The analyst will analyze the samples as per the respective sampling plan provided by the QA Department and submit the report to the QA Department.
• The analyst will analyze the Equipment Qualification samples according to the respective Specification and STP, attach the raw data (chromatographs, spectrographs, etc.), write the results on Analytical Raw Data Sheets (as per Annexure-II, Annexure-III, and Annexure-IV respectively) issued by the GLP person, and submit the data to the QA Department if required.
• Make an entry of the analysis status in the inward register's remarks column and provide the results to the Quality Assurance department through the received intimation slip.
• The Specification, STP, and Raw Data Sheet for Equipment Qualification batches will be prepared as per SOP.

Specification/STP Numbering:

• The first 9 digits are the specification number or STP number, and the last 2 digits are the revision number, represented as: XXX/YY001-ZZ

1. XXX: SPC or STP referring to specification or standard test procedures respectively
2. /: Slash
3. YY001: Specification/STP number of the Equipment Qualification (YY represents Equipment Qualification (EQ))
4. -: Dash
5. ZZ: Revision number (starting with “00” for the first version followed by sequential numbers for each subsequent revision)

For Process Validation Batches:

• The Quality Assurance Department will send samples from different stages of various Equipment from other locations, along with a requisition slip as per their sampling plan outlined in the respective Protocol.
• Upon receiving the samples, enter the inward register as per Annexure-III of the SOP.
• Generate the A.R. number for Process Validation samples using the format: VAL-0001/24

1. VAL: Validation Sample
2. 0001: Serial number of the sample
3. 24: Last two digits of the year (2024)

ALSO READ: SOP for Facility Design, Facility, Equipment and System Qualification

• Write the A.R. number on the requisition slip received with the samples from the QA Department.
• The analyst will analyze the samples as per the respective sampling plan provided by the QA Department and submit the report to the QA Department.
• The analyst will analyze the Process Validation samples according to the Specification and STP of the finished product, attach the raw data (chromatographs, spectrographs, etc.), write the results on Analytical Raw Data Sheets of the finished product issued by the GLP person, and submit the data to the QA Department if required.
• Make an entry of the analysis status in the inward register's remarks column and provide the results to the Quality Assurance department through the received intimation slip.

ANNEXURES

Annexure-I: Equipment qualification sample inward register

Annexure-II: Template for Equipment Qualification Specification

Annexure-III: Template for Equipment Qualification Standard Test procedure

Annexure-IV: Template for Equipment Qualification Analytical raw data sheet

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

REVISION HISTORY

Nil

ALSO READ: SOP for Equipments and Machines Qualification