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Descripción: Points of Validation after CIP in Pharmacy Industry.
Pharmaceutical cleaning validation
Pharmaceutical cleaning validation
Guia de inspeção de validação de limpeza, segundo protocolos da FDA
Points of Validation after CIP in Pharmacy Industry.Full description
EO sterilization validation protocol
COMPANY LOGO
COMPANY NAME Company Address
CLEANING VALIDATION PROTOCOL FOR AT:
Cleaning Validation Protocol
Document No.
:
For
Effective Date
:
Page No.
:
Revision No: R0
Supersedes: N/A
CVP/001
Page 2 of 15
INDEX S. No.
Content
Page No.
1.
Preapproval of Protocol
3 of 15
2.
Introduction
4 of 15
3.
Objective
4 of 15
4.
Scope
4 of 15
5.
Responsibilities
5 of 15
6.
Protocol Training Record
6 of 15
7.
Product Profile
6 of 15
8.
Equipment Description
7 of 15
9.
Methods of Cleaning
7 of 15
10.
9.1
Cleaning Procedures
7 of 15
9.2
Materials and Equipments used for cleaning
8 of 15
9.3
Cleaning SOP Index for each equipment
8 of 15
Sampling Method
9 of 15
10.1
Selection of Sampling Method
9 of 15
10.2
Scientific rational for selecting Sampling Points
9 of 15
10.3
Visual Inspection
9 of 15
10.4
Swab Sampling for Chemical Analysis of API
9 of 15
10.5
Sampling Patterns
10 of 15
10.6
Swab sampling for Microbial analysis
10 of 15
10.7
Swab sampling Location
11 of 15
11.
Analytical Procedure
12 of 15
12.
Establishment of Acceptance Criteria
12 of 15
12.1
Visual Inspection
12 of 15
12.2
Active Residue
12 of 15
12.3
Rational to Calculate Maximum Allowable Carry-Over Taking the Worst-Case
12 of 15
12.4
Rational to Calculate Maximum Allowable Carry-Over Taking the 10 ppm Criteria
13 of 15
12.5
Establishment of Acceptance Limits
13 of 15
12.5.1
Acceptance Limits per Equipment (ALE) for API
13 of 15
12.5.2
Acceptance Limits per Swab (ALS) for API
13 of 15
12.6
Acceptance Limits for Microbial Bio-burden
14 of 15
13.
Acceptance Limits for the Cleaning Agent
14 of 15
14.
Hold Time Study
15 of 15
15.
Revalidation Criteria
15 of 15
Cleaning Validation Protocol
Document No.
:
For
Effective Date
:
Page No.
:
Revision No: R0
Supersedes: N/A
CVP/001
Page 3 of 15
1. Preapproval of Protocol: Signing of this Protocol indicates agreement with the Cleaning validation approach established for . Further, if any changes in this Master Plan would be required, it will be revised and duly approved. Compiled By: Functional area
Name
Designation
Signature
Date
Name
Designation
Signature
Date
Quality Control
Production
Quality Assurance
Reviewed and Approved By: Functional area
HeadQuality Control
HeadProduction
Quality Assurance
Authorized By: Functional area
HeadQuality Assurance
Name
Signature
Date
Cleaning Validation Protocol
Document No.
:
For
Effective Date
:
Page No.
:
Revision No: R0
2
Supersedes: N/A
CVP/001
Page 4 of 15
Introduction: Cleaning Validation in the context of manufacture of the solid oral products at may be defined as: “The process of providing documented evidence that the cleaning method of the equipments and ancillary utensils employed within the facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.” (Source: APIC, September 1999) It is necessary to Validate Cleaning procedures for the following reasons: a) It is a customer requirement - it ensures the safety and purity of the product. b) It is a regulatory requirement in Active Pharmaceutical Ingredient product manufacture. c) It also assures from an internal control and compliance point of view the quality of the process.
3
Objective: The objective of this protocol is;
Objective of Cleaning Validation is to establish and assure with documented evidence that the cleaning procedures used after manufacturing of is effective and consistently performs as expected and produce a result that meets a predetermined acceptance criteria when manufactured.
To provide documented evidence through the scientific data to show that the cleaning procedure used after manufacturing of Tablet is effective and consistently performs as expected and produce a result that meets a predetermined acceptance criteria when manufactured.
To establish that the cleaning process shall provide a high degree of assurance for removal of residues of the last manufactured product, so that those residues are not transferred to the subsequently manufactured product.
4
To prove that equipment is consistently cleaned of product to an acceptable level to prevent contamination and cross-contamination
Scope:
The scope of this protocol is applicable for the Cleaning validation of
WITH API STRENGTH>
Also, to evaluate the acceptability of cleaning procedure used in cleaning of equipment using wellestablished analytical and microbiological method to determine the chemical and microbiological residue after cleaning of the equipment. This will also cover the responsibilities, sampling plan, acceptance criteria, re-validation criteria, and change control procedure. This protocol is applicable for .
Cleaning Validation Protocol
Document No.
:
For
Effective Date
:
Page No.
:
Revision No: R0
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Supersedes: N/A
CVP/001
Page 5 of 15
Responsibilities: 5.1
5.2
5.3
5.4
5.5
Quality Assurance:
5.1.1
To prepare the Cleaning Validation Protocol.
5.1.2
To review the Cleaning Validation Protocol.
5.1.3
To monitor cleaning activities.
5.1.4
To collect swab/rinse samples from cleaned equipment.
5.1.5
To review analytical reports.
5.1.6
To prepare and review cleaning validation report.
Production: 5.2.1
To review the Cleaning Validation Protocol.
5.2.2
To provide details of equipments.
5.2.3
To get the equipments cleaned by trained operators.
5.2.4
To schedule cleaning validation program.
5.2.5
To maintain log-books for equipment cleaning.
5.2.6
To review cleaning validation report.
Quality Control: 5.3.1
To review the Cleaning Validation Protocol.
5.3.2
To analyze the swab/rinse samples collected for cleaning validation.
5.3.3
To compile the analytical data.
5.3.4
To review cleaning validation report.
Quality Control (Microbiology): 5.4.1
To review the Cleaning Validation Protocol.
5.4.2
To collect Microbiological samples from cleaned equipment.
5.4.3
To analyze the cleaning validation samples.
5.4.4
To compile the Microbiological data.
5.4.5
To review cleaning validation report.
Head – Quality Assurance: 5.5.1
To review and to approve cleaning validation protocol and report.
Cleaning Validation Protocol
Document No.
:
For
Effective Date
:
Page No.
:
Revision No: R0
6
Page 6 of 15
Protocol Training Record: –
– –
7
Supersedes: N/A
CVP/001
All the personnel involved in the cleaning validation activity, sampling and testing of cleaning validation samples must be appropriately trained in their assigned job responsibilities and on the Cleaning validation protocol. Personnel or operator who performs cleaning routinely should be trained and should be trained and should be effectively supervised. Record the training details of the persons involved in the sampling and testing.
