1.0 Purpose
1.1
To provide guidelines in establishing a
scientifically sound Cleaning Validation Program, so as to establish the
validity of the respective equipment cleaning procedures.
2.0 Scope
2.1 This procedure is applicable to the
Cleaning Validation carried out at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Team of Cleaning Validation is responsible for proper execution of this SOP.
3.2 Head of Quality Assurance are responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
4.1 QA :
Quality Assurance
5.1 None
6.0 Precaution / Health and Safety
Considerations
6.1 SOPs for cleaning of all equipment shall
be in place.
6.2 Cleaning Validation shall include the
entire equipment train used for a given product.
6.3 Once established, re-validation shall be
every two-year interval.
6.4 Analytical method used for Maximum Carry
over (MACO) shall be validated
7.0
Procedure
7.1 Validation of cleaning procedures for equipment shall be carried out for 3 consecutive batch-to-batch changeovers or 3 batch products to product change over for a given product.
7.2 The Cleaning Validation shall be carried out simultaneously along with the process validation for a given product.
7.3 Individual protocols for cleaning validation shall be prepared for all products.
7.4 The protocols shall include:
Ø Objective
& Scope
Ø Task
force & their responsibilities
Ø List
of equipment to be subjected to validation
Ø Sampling
plan & methodology of rinse & swab sampling
Ø Method
of Analysis
Ø Validation
of Swab recovery
Ø Validation
report
Ø Conclusion
7.5 The Cleaning Validation Protocol shall be prepared by Officer QA, checked and reviewed by QC Manager, approved by Head of Quality Assurance.
7.6 Officer-IPQA/ QC/ Microbiologist, shall
carry out the sampling as per the sampling plan.
7.7 The acceptance criteria shall be based
on Maximum Carry Over for a given product (Reference
– Acceptance Criteria & Establishing Limits for Cleaning Validation).
7.8 MACO is established based on matrixing
and bracketing of the products.
7.9 A matrix of products, with their largest
daily doses and batch sizes shall be prepared. Based on the matrix, no. of worst-case doses shall be calculated.
7.10 The products in the matrix shall be
bracketed. The bracketing shall be done on the basis of different strength of actives for a given product.
7.11 In this bracket, cleaning for the highest
dosage strength shall be established and the validity shall be extrapolated for the lower strengths.
7.12 After cleaning of the equipment as per the
respective SOP for cleaning, rinse and swab samples
shall be drawn as per the sampling plan in the individual protocols.
7.14 To account for the loss during swabbing,
swab recovery validation shall be carried out for each product.
7.15 Validation of cleaning shall be carried
out for 3 consecutive batches of a given product and subsequently on one batch annually.
8.0
Reference Document
8.1 WHO
GMP Guideline trs-986; annex-2
8.2 In- house,
9.0 Annexure
9.1 None
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New, |
|
|
11.0 Training
11.1 Head of Quality
Assurance or his nominee give the training of Officers / Sr. Officer of
Production, Quality Control, Quality Assurance.
