1.0 OBJECTIVE
1.1 To describe a procedure for Qualification of Outsource Testing Facility.
2.0 SCOPE
2.1 This procedure is applicable to testing the outsource qualification
3.0 RESPONSIBILITY
3.1 Executive – Quality Assurance Department.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance.
5.0 PROCEDURE
5.1 Selection criteria
5.1.1 Outsource testing facility should have approved by any regulatory author minimum by local FDA, and should have GMP certificate.
5.1.2 The facility should be nearest to the company.
5.1.3 The outsource testing laboratory management should able to send their representative to collect the sample and deliver the test result.
5.1.4 The outsource testing laboratory management should have the facility carry the sample in lower temperature condition if required.
5.1.5 All terms and conditions shall agree by both company and outsource testing facility management.
5.1.6 A typical terms and conditions shall referred in QAD
5.1.7 Every once in a year the outsource testing laboratory shall audited and assessed by QC and QA department head or his designee.
5.1.8 Audit shall be performed as per the check list is given in QAD
5.1.9 Approved outsource testing laboratory details, validity shall documented in QAD
5.1.10 Validity of approval shall be a for one year.
6.0 TRAINING
6.1 Trainer – Head-QA.
6.2 Trainee – All Concern Person.
6.3 Period – One hour or as per required.
7.0 DISTRIBUTION
7.1 One set of master copy & controlled copy submitted the quality assurance department.
8.0 ENCLOSURE
8.1 Terms and condition.
8.2 Audit check list.
8.3 Qualification of outsource testing laboratory.
9.0 ABBREVIATIONS
9.1 SOP : Standard operating procedure
9.2 QA : Quality assurance
9.3 QC : Quality control
9.4 HOD : Head of department
9.5 GMP : Good manufacturing practices
9.6 No. : Number
9.7 cGMP : Current good manufacturing practices
9.8 FDA : Food drug administration.
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Outsource testing laboratory – Terms and Conditions
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| Name and address of Outsource testing laboratory. (Reception phone number)
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| Name and contact number of authorized person. (Direct phone number)
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| Name and contact person from QC. Department (Direct phone number)
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Terms and Condition:
1). Management of outsource testing laboratory should accept to audit at any time without prior intimation.
2). Analytical method should use only validated and approved methods by abc company For quantitative tests, or Pharmacopoeia methods for qualitative tests.
3). Any changes or deviation requires in the analytical methods must be intimate and take a prior approval from company QC-QA Department head.
4). Copy of analytical record should provide along with COA.
5). The sample shall not to be used any another purpose by outsource testing laboratory.
6). Any un-identified query’s regarding COA, Analysis test procedure must be provided to Shivalik Remedies Pvt. Ltd., QA-QC department at any time.
7). Any incidents or failures of the test results must be reported to Shivalik Remedies Pvt. Ltd.,QC department head. And investigated as per GMP procedure.
8). Change of the test must be pre-designed, and reviewed every once in a year.
Accepted and Approved By:
| Head of QC department | Authorized person from Outsource testing lab Name and Sign. | Head of QA department |
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OUTSOURCE TESTING LABORATORY – AUDIT CHECK LIST
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| Name and address of outsource testing laboratory.
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| Name and designation of Auditor
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| Name and designation of Audited
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| Sr. No. | Check Point | Observations |
| 1. | Is the QC Lab facility and systems meets the GLP standards. | |
| 2. | Sample storage facility during under testing is it ok. | |
| 3. | Are they have facility to provide proper storage condition during transportation of sample. | |
| 4. | Is the training program for technical staff available and following? | |
| 5. | Is the instruments and equipments are calibrating as per schedule. | |
| 6. | Is the technical staff qualification and experience. | |
| 7. | Are they having all required instrument and equipments? | |
| 8. | Is the instruments and equipments calibration schedule available? | |
| 9. | Working standards storage and usage is it as per SOP. | |
| 10. | Working standards preparation SOP available / is it preparing as per SOP. | |
| 11. | All instruments and equipments manufacturer brand is it ok. | |
| 12. | Is the microbiology testing facility meets requirement of current GMP/GLP standards. | |
| 13. | Is the laboratory having BET testing facility? | |
| 14. | Is the glass ware calibration performing? |
Note: 1). Attach separate sheet if need descriptive comments.
2). Provide copy for relevant documents wherever applicable.
| Audited By | Reviewed | ||
| QC | QA | QC | QA |
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QUALIFICATION OF OUTSOURCE TESTING LABORATORY
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| Sr. No. | Parameter | Description / Status / Availability |
| 1. | Name of Outsource testing laboratory.
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| 2. | Address
(With contact person name and phone number) |
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| 3. | Established on
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| 4. | NABL Certified / Date of issue
(Copy to be attached) |
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| 5. | Any other Regulatory Approvals
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| 6. | Technical person
(Name, Qualification and experience detailed copy to be attached) |
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| 7. | Facilities
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| 8. | Audit as per check list
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| 9. | Systems
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| 10 | Management capabilities
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Note: 1). Over all satisfactory level shall be indicated as Excellent / Very Good / Good / Average / Poor.
2). Specify Available / Not Available and Applicable / Not Applicable.
Qualification Done By: Reviewed By:
(QC Department) (QC Department)
| 11 | Approver comments
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| Approval for
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Chemical testing | Microbiology testing | |
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| 12 | Approval valid up to
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Reviewed By: Approved By:
(QC Head) (QA Head)