REFERENCE PROTOCOL NO.	:
GENERIC NAME	:	PARACETAMOL & MEFENAMIC ACID SUSPENSION
BLOCK	:	PRODUCTION
AREA	:	ORAL LIQUID
EFFECTIVE DATE	:

TABLE OF CONTENTS

Sr. No.	Content
	Objective
	Scope
	Responsibility
	Reference document
	Training
	Validation Methodology, Test procedure and Acceptance Criteria
	Observation and Results
	Deviation and Failure Investigation
	Summary and Conclusion
	Recommendation
	Attachment
	Abbreviation
	Report Approval

1. Objective:

To provide evidence that the cleaning procedure employed, the reliability of equipment cleaned and the training of the operators executing the procedure are effective, reproducible and adequate to achieve consistent predetermined levels of cleanliness thereby ensuring safety & efficacy of the product.

• Scope of Validation Activities:

The scope of this report applies to the Cleaning Procedures to be followed in Liquid block at Quixotic Healthcare, Baddi.

• Responsibility:

Department	Responsibilities
Quality Assurance	Preparation and approval of Report.Execution of Cleaning Validation Activities. Monitoring the sampling at the different time interval as per the Protocol.Handling of Deviations. Training of team involved in cleaning validation.Compilation of all test data Verifying the cleaning activitiesAuthorization of final report.
Production	Review of Report.Cleaning of equipments and control on equipments during hold time study Provide support to QA for Execution of activity as per protocol.Approval of the report
Quality Control (Chemical)	Review of Report.Chemical analysis of samples Preparation of test data sheet Submission of data to QA.
Quality Control (Microbiology)	Sampling and analysis of samples for microbiological examinationPreparation of test data sheet Submission of data to QA.
Engineering	To review of report To provide support with respect to equipments during cleaning validation.Responsible for trouble shooting in equipments (if occurred during execution)

• Reference document:

Sr. No.	Document Name	Ref. No & Revision No.

• Training:

Training is provided to all concerned person involved in the validation activity and training record attached as Annexure.

• Validation Methodology, Test procedure and Acceptance criteria;

For detail methodology, testing procedure.

• Observation and Results:
  • Microbial Analysis Results:

Equipment	Eq. ID No.	Sampling Point Location	Sampling Point No.	Result of microbial analysis (CFU) (Limit: NMT 100 cfu /25cm2)

• Chemical  Analysis Results:

  (1)  PARACETAMOL

Equipment	Eq. ID No.	Sampling Point Location	Sampling Point No.	Result of chemical analysis (PPM)

(2)  MEFENAMIC   ACID

Equipment	Eq. ID No.	Sampling Point Location	Sampling Point No.	Result of chemical analysis (PPM)

• Deviation and failure Investigation

No deviation /OOS observed from the acceptance criteria specified in the protocol.

• Summary and Conclusion:

Cleaning validation of Liquid block (For Paracetamol & Mefenamic Acid) done as per approved protocol.

Training is provided to all concern persons before starting the validation activity.

Cleaning of equipment was done as per approved cleaning procedure of respective equipment. The sampling was done by trained microbiologist for microbial analysis & by trained QA chemist for chemical analysis after visual inspection of area and equipment. Microbiological results reviewed and maximum CFU observed is 20 cfu/25 cm² against the acceptance limit of NMT100 cfu/25 cm².  Results of chemical analysis reviewed and maximum content of residue observed during chemical analysis is 0.20ppm which is less than the acceptance criteria i.e. NMT 10 ppm /rinse. For Paracetamol and 0.20ppm  which is less than the acceptance criteria i.e. NMT 10 ppm /rinse. For Mefenamic Acid.The relevant documents and records are verified and are found updated. No deviation or non conformance observed during study.

From the above summary it is conclude that cleaning validation of Paracetamol 125 mg and mefenamic Acid 50 mg.completed successfully and meet the acceptance criteria as defined in cleaning validation protocol.

1. Recommendation:

The results shows that the cleaning process is adequate for cleaning of manufacturing equipment and thus existing procedure shall be continued.

1. Attachment:

Attachment  No.	Attachment Title
	Training record
	Verification record of cleaning activity & reference SOP
	Visual inspection record of cleaned equipment
	Swab sampling record and results of microbial analysis
	Swab sampling record and results of chemical analysis

1. Abbreviation

Abbreviation	:	Full Form
SOP	:	Standard operating Procedure
cfu	:	Colony forming unit
OLD	:	Oral Liquid Dosage
QA	:	Quality Assurance
%	:	Percentage
SS	:	Stainless Steel
PPM	:	Part per million

1. Report Approval:

 

Compiled By:

Functional Area	Name	Designation	Signature & Date

Reviewed By:

Functional Area	Name	Designation	Signature & Date

Approved By:

Functional Area	Name	Designation	Signature & Date

 

Authorized By:

Functional Area	Name	Designation	Signature & Date