SOP for External Laboratory Testing | SOP for Contract Laboratory Analysis |
1.0 OBJECTIVE :
- To lay down a procedure of contract laboratory approval and contract analysis.
2.0 SCOPE :
- This SOP is applicable for contract laboratory approval and contract analysis by Quality Control Department.
3.0 RESPONSIBILITY :
- Quality Control Officer and above
- Quality Control Head
5.0 PROCEDURE :
5.1 The testing parameters that cannot be performed in the in-house established laboratory shall be carried out by authorized external competent laboratory. However, in case of emergent situation mentioned as follow, the sample shall be sent to authorized external competent laboratory,
- Breakdown of instrument/facility.
- Non availability of chemicals/reagents/impurities/media/culture.
- Temporary increase in analytical load.
5.2 A contract agreement for analysis should be signed off between the Contract Giver and the Contract Acceptor (authorized external competent laboratory / contract laboratory) which specifies their respective responsibilities relating to the analysis and control of the product.
5.3 All arrangements for analysis must be in accordance with the Specification and agreed by both parties.
5.4 The contract laboratory must have adequate premises, facilities, equipment and knowledge, necessary approval from drug regulator besides experience and competent personnel to perform satisfactorily the service requested by contract giver.
5.5 The written and signed contract agreement must clearly establish the duties/ responsibilities of each party with all the technical activities related to both.
5.6 The contract should permit the Contract Giver to visit / audit the facilities of the Contract Acceptor (contract laboratory) to ensure GDP / GLP complies of the specific operation occurring at the contract site as per format of checklist of external laboratory Annexure No. 03.
5.7 All contract laboratories should comply with GLP and GDP defined in the guideline.
5.8 Re-visit/ re-audit shall be scheduled after every 3 years or earlier and based on this; contract shall be revised, if required.
5.9 The re-audit will be conducted 15 days before the expiry of the certificate if it intends to continue.
5.10 Contract giver will inspect the testing site at any time it deems necessary within the validity of this certificate based on risk / routine frequency.
5.11 Contract laboratory audit observation report shall be sent to contract laboratory with observation and recommendation in Annexure No: 04.
5.12 The numbering system for Audit report number is as follows;
- QC = Stand for Quality Control
- XXXX = Stand for short form of contract laboratory
- YY = Stand for number of audit to be carried out.
- ZZ = Stand for last two digit of year in which audit to be performed.
5.13 Contract laboratory shall inform Contract Giver of any inspections by the FDA or other agencies which relate to SAMPLE handling and testing. Following the inspection and resolution of any observations, contract laboratory shall furnish Contract Giver with a copy of the inspection letter that confirms the compliance of the operations.
5.14 Any critical or major deficiencies noted by an FDA or other Medicines Inspector during an audit of contract laboratory premises must be brought to the attention of Contract Giver.
5.15 Any such observations related directly to a Contract Giver product or sample, Contract Giver will be notified.
5.16 Contract Giver may also be consulted or requested to assist in the preparation of any response or corrective action plan.
5.17 If any regulatory audit fails then contract laboratory should inform to contract giver.
5.18 Analytical records should be kept at the site of Contract laboratory where the activity occurs and be readily available.
5.19 The Contract laboratory should not pass to a third party any of the work entrusted under the contract without the Contract Giver’s prior evaluation and approval of the arrangements.
5.20 Arrangements made between the Contract laboratory and any third party should ensure that the analytical information is made available in the same way as between the original Contract Giver and Contract laboratory.
5.21 Changes in the process, equipment, test methods, specifications or other contractual requirements should not be made unless the Contract Giver is informed and approves the changes.
5.22 The Contract laboratory should refrain from any activity which may adversely affect the quality of the product analyzed for the Contract Giver.
5.23 After receiving testing samples, section head shall identify the testing parameter of sample to be sent for analysis to the contract laboratory.
5.24 Sample shall be sent along with analytical sample slip, Annexure No.: 02 by courier or by hand delivery.
5.25 Sample to be sent should be packed properly as per storage condition of the sample and affix the label as per Annexure No.: 01.
5.26 Specification and standard testing procedure shall be provided to contract laboratory with each consignment, if required.
5.27 The details of the sample to be sent shall be recorded in contract laboratory sample record, Annexure No.: 05.
5.28 Contract laboratory must have an effective system for the receipt, logging, storage, traceability and destruction of samples, reference standards and reagents.
5.29 Any determined OOS results or GLP/GDP deviation must be reported to Contract Giver within 24 hours of confirmation.
5.30 In case of any Out of Specification results found during contract analysis, then the contract laboratory should follow their in-house OOS investigation procedure.
5.31 The OOS result or GLP/GDP deviation is fully documented and investigated with any subsequent actions implemented.
5.32 The contract laboratory should convey its data, finding and supporting document to Contract Giver.
5.33 If in case excess of samples require for Investigation then Contact Giver should provide the quantity as required by the contract laboratory for further investigation.
5.34 In case of OOS is confirmed in preliminary OOS investigation at contract laboratory, Contact Giver should initiate.
5.35 Contract Giver shall advise to contract laboratory in case of any OOT results on carrying out trend analysis. Contract laboratory will investigate the OOT results.
5.36 In case of contract analysis, the final approval for the clearance of the finished product for trade must be given by the authorized person of Contract Giver only.
5.37 Contract laboratory will dispose of analytical samples only when their testing is fully completed and approved. In the event of any OOS/OOT, relevant samples will be retained to enable a thorough investigation.
5.38 Contract laboratory shall perform the analysis and send report with raw data.
5.39 The analytical report number and results of the testing parameter shall be taken by a mail or telephonically if issues in receiving of mail and release the material and reports shall be collected thereafter.
5.40 After receiving the report from contract laboratory, section head shall verify the report. Section head shall stamp and sign as “verified by” with date in each page of report and raw data.
5.41 The same result is mentioned in record at particular Lot analysis in the component.
5.42 The material/product shall be released by taking into consideration the result of contract laboratory of that testing parameter which was tested in contract laboratory.
|Standard Operating Procedure
|Certificate of Analysis
|Good Laboratory Practice
|Good Documentation Practice
|Out of Specification
|Out of Trend
|Food and Drug Administration
|Analytical Sample Slip
|Checklist of Contract Laboratory Audit
|Contract Laboratory Audit Observation Report
|Contract Laboratory Samples Record
8.0 SOP REFERENCES
- Orange Guideline MHRA – Rules and Guidance for Pharmaceutical Manufacturers and Distributors – 2014 (Section-II, Contract Manufacture and Analysis)
END OF THE SOP
Annex. No. 01 Sample Label
Annex. No. 02 Analytical Sample Slip
Annex. No. 03 Checklist of Contract Laboratory Audit
Annex. No. 04 Contract Laboratory Audit Observation Report
Annex. No. 05 Contract Laboratory Samples Record