1.0 Objective
To lay down a procedure for qualification of external calibrating agency.
2.0 Scope
This Standard Operating Procedure is applicable for qualification of external calibrating agency, for instruments /equipment for which in-house calibration facility is not available at pharmapathway.
3.0 Responsibility
3.1 Heads of Engineering, Quality Control and Quality Assurance departments or their designee shall be responsible for assessing and approving the external calibrating agency as per procedure mentioned in this SOP.
3.2 Head, QA or his designee shall authorize the external calibrating agency.
4.0 Abbreviations and Definitions
QA – Quality Assurance
SOP – Standard Operating Procedure
5.0 Procedure
5.1 Head, QA or his/her designee in consultation with Head Engineering shall initiate qualification of external calibrating agency by sending “Questionnaire for Evaluation of Calibrating Agency” (Annexure-I) to the prospective agency/laboratory.
5.2 Head, QA or his/her designee after receiving the filled questionnaire shall evaluate and assess the need of the site audit of the external calibration agency. The site audit, if required, shall be planned along with Head, Engineering and QC or their designee.
5.3 In case of audit, the external calibrating agency shall be informed in advance.
5.4 On the basis of audit’s findings and/or Questionnaire for Evaluation of Calibrating Agency, Head QA shall decide the approval of calibrating agency.
5.5 Respective heads of Engineering, QC and QA shall finally be responsible for approval for external calibrating agency through Annexure –III.
5.6 If calibrating agency qualifies, then Head, QA shall intimate the concerned person from Intellectual Property Rights and Legal Affairs Department for preparation of written contract (see specimen attached as Annexure-II) with external calibrating agency if applicable.
5.7 Intellectual Property Rights and Legal Affairs department shall provide a copy of written contract to QA.
5.8 Master copy of “Certification – Qualification of External Calibrating Agency” (Annexure-III) shall be maintained at QA and a copy shall be provided to QC and Engineering for their record.
6.0 Forms and Records
6.1 Questionnaire for Evaluation of External Calibrating Agency – Annexure-I
6.2 Specimen Contract for Calibration Services – Annexure-II
6.3 Certification – Qualification of External Calibrating Agency – Annexure-I
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copies – Quality Control, Engineering, Intellectual Property Rights, Legal Affairs, Quality Assurance
8.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Questionnaire for Evaluation of Calibrating Agency
To be filled by Pharmapathway
Name of Contact Person/ Address:
E-mail:
Sent On: Sent By:
Received On: Received By:
Remarks (if any):
Head, Quality Assurance
(Sign/Date)
To be filled by the Calibrating Agency
Name and Address of the agency:
Name of the Incharge of the agency:
Phone No.: Fax No.:
E-mail:
Contact person (if other than agency Incharge):
Accreditation by [Name of Agency like ISO, National Accreditation Board for Testing Calibration Laboratories (NABL), BIS etc.]:
Organizational membership (if any):
Note: Where ever required, information can be given as annexure
| S. No. | Qualification Aspects | Yes/No/N.A. | Remarks (if any) |
| Organization and Management | |||
| 1. |
Is the Agency organized in such a way that confidence in its independence of judgement and integrity is maintained at all times? |
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| 2. | Does the Agency provide supervision by persons familiar with the test methods and procedures, the objectives of the testing and the assessment of the results? | ||
| 3. | Does the Agency have a technical manager who has overall responsibility for the technical operations? | ||
| 4. | Does the Agency have a quality manager who has responsibility for the quality system and its implementation?
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| 5. | Is the quality system reviewed at least once a year by the management to ensure its continuing suitability and effectiveness? | ||
| 6. | Does agency procures outside services or supplies? | ||
| 7. | Does qualified person receive equipments? | ||
| 8. | Is any documentation or coding used to track a equipment received for calibration? | ||
| Quality Control Manual | |||
| 9. | Does the Agency maintain a Quality Control Manual or any other appropriate system containing, as a minimum, the following:
a. a quality policy statement, including objectives and commitments, by top management, b. the organization and management structure of the Agency, c. the relationship between management, technical operations, support services and the quality system, d. procedures for control and maintenance of documentation, e. job descriptions of key staff and reference to the job descriptions of other staff, f. identification of the Agency’s approved signatories, g. arrangements for ensuring that the Agency reviews all new work to ensure that the Agency has the appropriate facilities and resources before commencing such work, h. reference to the test procedures used, i. reference to procedures for calibration, verification and maintenance of equipment, j. list of codes and standards maintained for reference by the Agency, and k. procedures for audit and review? |
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| Personnel | |||
| 10. | Does the Agency have sufficient personnel, with the necessary education, training, technical knowledge and experience for their assigned functions? | ||
| 11. | Are records on the relevant qualifications, training, skills and experience of the technical personnel maintained by the laboratory? | ||
| 12. | Is there a training program described in the Agency’s written practice? | ||
| 13. | Are eye examinations required for all inspection personnel? | ||
| 14. | Are outside agencies used for training and examining personnel? | ||
| Facilities and Equipment | |||
| 15. | Are the facilities, equipment, instructions, and specifications adequate for the type of work to be performed? | ||
| 16. | Are adequate procedures in effect to control the maintenance, calibration, and use of equipment including applicable tools, gauges, and other instrumentation? | ||
| 17. | Is equipment (tools, gauges, and other instruments) identified to reflect:
a. date last calibrated, b. date of next calibration, and c. identification or serial number? |
||
| 18. | Is the environmental condition of laboratory maintained and recorded? | ||
| 19. | Equipments/Instruments available for testing (give list along with their manufacturers). | ||
| 20. | Is there any schedule for performing calibration of equipments? | ||
| 21. | Are internal standards used for calibration traceable to any National / International Accreditation Agency? | ||
| 22. | Are there written procedures for operation and calibration of instruments? | ||
| Project Administration and Documentation Procedures | |||
| 23. | Are contract requirements reviewed to ensure specification compliance with applicable codes, standards and specifications? | ||
| 24. | Are inspection and test results documented and reported as required? | ||
| 25. | Are the results of each test, or series of tests, reported accurately, clearly, unambiguously and objectively? | ||
| 26. | Does the Agency have the ability to provide inspection services at offsite fabrication facilities? | ||
| 27. | Is there any instrumentation-training programme? | ||
| 28. | What is the proposed lead time for reporting of results/ dispatch of results? | ||
| 29. | Is there any preventive maintenance programme for instruments? | ||
| 30. | Are all data (final report and related raw data) reported to client? | ||
| 31. | Does agency retain records of original observation, derived data and test records? | ||
| 32. | Are records legible, readily retrievable and have a procedure for backup of records stored electronically? | ||
| 33. | Are all the tests being performed as per client’s requirements? | ||
| 34. | Are the testing reports signed and dated by analyst? | ||
| 35. | Are the testing records counter checked / signed by Incharge before dispatch of report? | ||
| 36. | Does the laboratory have procedures to control all documents forming part of quality system e.g. regulations, standards, test methods, specific instructions, etc. | ||
| 37. | Are all documents issued to personnel in laboratory, reviewed and approved by authorised personnel before issuing? | ||
| 38. | Are written procedures/test methods reviewed and updated?
|
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| 39. | Are written procedures for calibration of equipments if received from client properly documented?
|
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| 40. | Is there a protocol that requires the client to be notified of changes made to test procedures? | ||
| 41. |
Is there any procedure for informing the client in case any equipment is failing in calibration and any remedial action that can be taken? |
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Please enclose list of following documents:
- Organogram (with qualification, experience and job responsibilities of key personnel).
- Copy of certificates of approval by State Authorities or any other approval.
- List of Equipments/Instruments with make/model No. along with the mention of calibration of critical Instruments
- List of Master/standard equipments used along with their source.
- List of SOPs.
- List of clients.
Name & Address of Proprietor / Owner / Technical person:
Date:
Annexure-II
SPECIMEN CONTRACT FOR CALIBRATION SERVICES
BY AND BETWEEN
Pharmapathway
AND
M/s._________________________________________________________________________________________________________________________________________________, who hereby declare that none of us is/are not related to any Director, of Pharmapathway. In which any of us or relative is a Director/Proprietor/Partner, member or firm in which such director or relative of such Director is a partner/proprietor in any way whatsoever.
- Scope of Agreement
It includes the following services:
a) ____________________________ shall carry out the calibration of process control devices, viz. Digital Temperature Indicator and Controller, Temperature Sensors Gauges, Weighing Balance, Weight Box, Incubators, Pressure and Vacuum Gauges, Portable pH meters, Bench type pH sensors etc., as required by Pharmapathway.
b) ____________________________shall carry out the calibration as per the Master Calibration Plan. The calibration schedule of equipments and instruments shall be intimated to ____________________________by Pharmapathway.
c) Calibration shall be carried out strictly as per standard written calibration procedures before implementing it.
d) Calibration shall be carried out strictly as per standard written calibration procedure.
e) ____________________________shall notify any change in the standard, equipments and procedures before implementing it.
f) Supporting documents to master calibrators shall be made available by ____________________________.
Information including: Data, know-how, formulae process, design specification, samples, photographs, sketches, results of experimental reports and any evaluation derived from there shall be provided by ____________________________.
- Validity
The Term of this Contract shall be for year commencing from ____________________________and terminating on ____________________________.
- Either party can terminate the Contract by giving 30 days notice served on the above addresses of the parties.
- The rates changes per item shall be communicated by ____________________________to Pharmapathway.
Signed on behalf of:
Pharmapathway Name of the Company / Acceptor
Address
Annexure-III
Certification – Qualification of External Calibration Agency
| Name of Contract Acceptor | : | |
| Address
Tel. Nos., Fax No. |
:
: : |
|
| Name of contact persons | : |
|
| Parameter evaluated | Done by | Remarks
(Ok/Not Ok) |
||
| Department | Name | Sign / Date | ||
| Technical Feasibility | Engineering | |||
| Technical Feasibility | QC | |||
| Quality systems | QA | |||
On the basis of evaluation of results, Qualification of External Calibration agency
Approved / Not Approved.:…………………….
Remarks
Head, Engineering Head, QC Head, QA
Sign/Date Sign/Date Sign/Date
