Handling of external laboratory activities
To lay down a procedure for qualifying, auditing, sending samples with reference to testing procedures, and obtaining the results for the same.
This SOP is applicable to all the external laboratories to which the samples are sent for testing due to the non-availability of in-house facilities/resources.
PROCEDURE
The external laboratory will be selected based on local government approval to the same, thus qualifying it as a government-approved testing laboratory
The non-government external laboratory will be audited by the QC Head and QA Head on annual basis.
The non-compliances will be communicated to the authorized personnel of the external laboratory and the compliance report with the target date of compliance will be obtained from them.
If felt necessary a follow-up audit will be performed.
All the activities between Pharma Company and the external testing laboratory will be governed by a “Technical Agreement”.
Each time when the sample is sent for analysis, the “Analysis request format” will be initiated in duplicate and the original copy will be sent along with the samples.
The reference number for the “Analysis request format” as mentioned in Attachment-1 will be given as “PC/QC/XXXX”
Where PC stands for Pharm Company
QC: Quality Control
XXXX: is a number starting from 0001
In case there is a change in procedure to the already submitted method of analysis then the latest version of the method will be sent along with the sample and the previously submitted method will be retrieved.
In the case of Pharmacopoeia methods, the reference to the relevant Pharmacopoeia will be given.
The sample sent for analysis will bear the label with the following details
- Name of material with Pharmacopoeial status where applicable
- Batch number
- Material receipt number (MRN)
- Manufacturing date
- Expiry date
- Signature and date
The external laboratory will receive the samples and give the results after analysis
In case any out-of-specification (OOS) test result is obtained, the external laboratory will inform the QC and QA of the Pharma Company in writing and an OOS investigation will be performed.
In case of any quality impacting changes made, the external laboratory will inform of the same to the QC and QA of Pharma Company and the same will be evaluated through the Change Control procedure.
