SOP for Assessment of Transit Impact on Drug Product

1.0 OBJECTIVE:

To lay down the procedure for Assessment of transit impact on drug products using Assessment Sample or by using Data Logger.

2.0 SCOPE

The scope of this SOP is to assess of transit impact on drug product by Temperature mapping during transit or Sample analysis.

Frequency: One time seasonal validation and Minimum three times in a Year for different destination.

3.0 RESPONSIBILITY:

3.1 Head BSR or designee – To place the data logger inside the shipment and related documentation.

3.2 Head QA – To coordinate for data logger related activities and evaluate the data of data logger and assess the impact of transit on drug product.

4.0 PROCEDURE:

4.1 Product Quality Evaluation by using Assessment Sample.

4.1.1 Assessment samples shall be sent with shipment or QP (Qualified Person) sample shall be considered as assessment sample. The Assessment sample quantity shall be sufficient for three analyses.

4.1.2 The details of assessment samples and location identity shall be recorded and copy of this record shall be sent along with dispatch documents.

4.1.3 The shipper / box contained assessment samples shall have clear identification mark, precautions displayed on it.

4.1.4 The receiver or QP shall withdraw the samples as per their procedure.

4.1.5 Get the copy of COA (certificate of analysis) for assessment sample analysed at receiver end.

4.1.6 Head QA or designee shall assess the impact of transit by comparing COA of location and transit sample analysed by receiver as per annexure II and records shall be maintained.

4.1.7 Head – QA or designee shall conclude on basis of this comparison and recommend Corrective Action and Preventive Action (CAPA) (if any) as per annexure II otherwise put NA remarks and close the CAPA accordingly.

4.1.8 In case of any unusual observation during assessment of transit impact the same shall be informed Head – CQA, Head – R&D (F) and other concerned for the same.

4.2 Transit Impact Assessment using Temperature Data logger and Assessment Samples

4.2.1 In order to monitor the temperature during transit for Impact Assessment of drug product Data Logger (temperature recorder) shall be put along with sample in shipper/Box for which Transit Impact Assessment shall be done.

4.2.2 Data logger in consignment shall be arrange by BSR.

4.2.3 While assessment of transit impact in addition to evaluating matter on base of comparing COA of location and transit sample, the record of temperature mapping done through data logger also taken in to consideration if provided by receiver.

4.3 Transit Impact Assessment using Temperature Data logger

4.3.1 In order to monitor the temperature during transit for Impact Assessment of drug product Data Logger (temperature recorder) shall be put along with sample in shipper/Box for which Transit Impact Assessment shall be done.

4.3.2 Data logger in consignment shall be arrange by BSR.

4.3.3 While assessment of transit impact by Temperature Data logger, the record of temperature mapping done through data logger provided by receiver.

4.4 Transit impact assessment with sample analysis shall be carried out to cover seasonal variations for each destination as per annexure III.

4.5 Numbering of Protocol

4.5.1 Number shall be give as [numbering should be developed by company]

4.6 Assessment for seasonal variation determine by doing study of six month data.

5.0 ANNEXURE (S):

Annexure I: Data Logger Details

Annexure II: Comparison of analytical results

Annexure III: Protocol on Impact Assessment of Transportation of finished product

Annexure I Finished Goods Stores

Data Logger Details

Ref. No.:

Date:

To:

From: Finished Goods Store.

Please find the following Data Logger dispatched to you in Box / Last Shipper No.:

Along with our export consignment.

Data Logger No.

Product Name

Batch No.

Pallet No.

Container No.

Inserted and Checked By / date:

F.G. Store Officer

Note: Please send us copy of COA for transit sample along with decoded temperature data of data logger (If Applicable).

Annexure II: Comparison of analytical results

Product

Batch No.:

Test:

Specification:

Results Contract Acceptor:

Results Contract Giver:

Date of analysis:

Done by/ date:

Conclusion:

Corrective action:

Preventive Action:

Closing Status:

Annexure III

PROTOCOL ON IMPACT ASSESSMENT OF TRANSPORTATION OF FINISHED PRODUCT:

Department:

Protocol No.:

01.0 INDEX:

00.1 Index

02.0 Protocol Approval

03.0 Objective

04.0 Scope

05.0 Responsibility

06.0 Acceptance Criteria

07.0 Procedure

08.0 Deviation History

09.0 Attachment (if any)

10.0 Final Report

02.0 PROTOCOL APPROVAL :

Prepared By/ Date

Checked By/ Date

Approved By/ Date

03.0 OBJECTIVE :

The objective of this protocol is to define a procedure for assessing the Impact of transportation on the quality, safety, integrity, strength and purity of the drug product in order to assure that the drug product is not affected during transportation from the site of manufacturing to contract giver.

04.0 SCOPE :

The purpose of this study is to determine the impact of environment and handling during transportation of the drug product from manufacturer to contract giver.

Seasonal study shall be carried out one time and every year for at least three batches of any products of different destination.

05.0 RESPONSIBILITY:

05.1 QA person:

a. To initiate the study based on the approved protocol.

b. To generate the data.

05.2 Head Quality Assurance :

a. approve protocol.

b. To review complied report.

c. To approve final report.

06.0 ACCEPTANCE CRITERIA :

There should not be any significant variation in the results of quality parameters of the finished product analysed as per the method of analysis. Mainly not complies with the specification or change in potency observed mote than 5 % of initial result.

In Case of the Impact Assessment done using only Temperature Data Logger, only Temperature Data shall be review for Conclusion

07.0 Procedure :

1) Compare COA prepared by [Company name] with COA supplied by QP or contract giver for all test parameter specified and / or review the trend obtained from data logger placed in container.

2) Note down any significant change observed in value. Record in deviation history.

3) Any other observation or remark from contract giver in communication to particular supply.

4) On basis of above findings prepare a summary report.

5) Assign corrective action and preventive action (CAPA) in matter if any.

6) After implementation and compliance of CAPA, the QA head will conclude the assessment to close the assessment study.

08.0 Deviation History :

Period of review : _________________ to ___________________

Deviation record :

Read By / Date :

Head QA/Date

09.0 Attachment (If any) :

10.0 FINAL REPORT :