ASSESSMENT OF CONTRACT ANALYTICAL LABORATORY FOR QUALIFICATION

ASSESSMENT OF CONTRACT ANALYTICAL LABORATORY FOR QUALIFICATION

PURPOSE: To lay down the procedure for Assessment of Contract Analytical Laboratory for qualification.

 SCOPE: This Standard Operating Procedure is applicable for qualification of Contract Analytical Laboratory for analysis of samples for which in-house testing facility is not available.

RESPONSIBILITY:

Preparation of SOP: Officer/Sr. Officer QA Department

Checking and Review of the SOP: Executive QA Department

Approval of SOP: Executive/Sr. Executive QA Department

Authorization of SOP: Head QA/Designee

Manager of Quality Control and Quality head / Technical shall make assessment and approval of the contract analytical laboratory as per procedure mentioned in this SOP. Head-Quality or Technical shall authorize the laboratory for contract analysis.

ACCOUNTABILITY:   The accountability of implementation and compliance of the SOP Concerned department Head and Head QA

PROCEDURE:

Head Quality Control or his/her designee shall initiate qualification of contract acceptor by sending “Questionnaire for Evaluation of Contract Analytical Laboratory as per Format No. SOP/C/QA052-F01 to the prospective laboratory.

Head Quality Control or his/her designee, after receiving the filled form “Questionnaire for Evaluation of Contract Analytical Laboratory” from the Contract Analytical Laboratory, shall evaluate and forward it to Head Quality or his/her designee with comments, if any.

Head Quality or his/her designee shall evaluate the questionnaire, and the site audit shall be planned along with Manager QC or his/her designee.

Requirement of site audit shall be planned based upon the accreditation and approvals of contract testing lab by the representative of contract giver. The Contract giver shall intimate the contract acceptor well in advance.

Contract testing lab shall send the corrective and preventive action on the observations and findings given at the time of audit within 30 working days after submission of audit report. Re-audit may or may not be done based upon the confidence level on corrective and preventive action submitted by the contract testing lab.

Compliance audit shall be based upon the current status of accreditations and approvals of contract testing lab. If required, compliance audit shall be conducted once in two years as per audit planner as per Format ‘Audit Planner of contract analytical laboratory for post qualification.

On the basis of audit’s findings and/or Questionnaire for Evaluation of Contract Analytical Laboratory, Head-QA shall decide the approval of Contract Acceptor.

Signed audit report shall clearly define the observations and findings. Conclusion shall be written at the end of audit report.

If Contract Acceptor qualifies for approval, then Head Quality/ Technical shall forward the Written Agreement as per Format to the Contract Acceptor for signing of the written agreement.

The Contract Acceptor shall send back signed copy to Head Quality/ Technical Then Head Quality/ Technical shall sign written agreement and shall provide copy of the agreement to QC and Contract Acceptor.

Then Head Quality/ Technical or his/her designee shall dispose the form “Certification Qualification of Contract Analytical Laboratory” as per Format No. SOP/C/QA052-F03 and update list as per SOP/C/QA052-F05 after Qualification for evaluation of calibrating agency.

Master copy of “Certification – Qualification of Contract Analytical laboratory” as per Format shall be maintained by QA and a copy shall be provided to QC.

REFERENCE:                    

• SOP for SOP
• Change control procedure

QUESTIONNAIRE FOR EVALUATION OF CONTRACT ANALYTICAL LABORATORY

• Is there any general housekeeping schedule?
• Is the environmental condition of laboratory maintained and recorded?
• Does qualified person receive samples?
• Is any documentation or coding used to track a sample received for test?
• Are samples adequately stored before and after testing?
• For how long samples are stored after test results are reported?
• Is the storage facility for samples monitored for temperature and humidity?
• Equipment’s/Instruments available for testing (give list along with their manufacturers).
• Is there any schedule for performing calibration of equipment?
• Is calibration performed internally or through external agencies?
• In case of external agencies, give names and addresses.
• Are internal standards used for calibration traceable to any National / International Accreditation Agency?
• Are there written procedures for operation and calibration of instruments?
• Is there any preventive maintenance programmed for instruments?
• Is there any instrumentation-training programmed?
• Is the training programmed documented?
• Is there any SOP for maintaining the documents/records of the laboratory?
• What is the proposed lead time for reporting of results/ dispatch of results for:

1. Chemical Analysis (Should not be more than 3 days)
2. Microbiological Testing (Should not be more than 10 days)
3. Sterility Testing (Should not be more than 20 days)

• Are all data (final report and related raw data) reported to client?
• Does laboratory retain records of original observation, derived data and test records?
• Are records legible, readily retrievable and have a procedure for backup of records stored electronically?
• Are all the tests being performed as per client’s requirements?
• Is there a SOP on Out-of-Specification test results?
• Is Out-of-Specification test results investigated and evaluated?
• Does the laboratory have a policy and procedure(s) for tests results that do not comply with its own procedures /specifications or agreed requirements of the client?
• Is the testing reports signed and dated by analyst?
• Are the testing records counter checked / signed by QC Incharge before dispatch of report?
• Do you have a Quality Manual including quality system policies and objectives?
• Does the laboratory have procedures to control all documents forming part of quality system e.g. regulations, standards, test methods, specific instructions, etc.
• Are all documents issued to personnel in laboratory, reviewed and approved by authorized personnel before issuing?
• Do you have the latest copies of Pharmacopoeias i.e. I.P., B.P., U.S.P.
• Are written procedures/test methods reviewed and updated?
• Are written procedures for testing of samples received from client properly documented?
• Is there a protocol that requires the client to be notified of changes made to test procedures?
• Are the chemicals and media purchased through approved vendors?
• Is ledger maintained for stock of chemicals and media?
• Is First In First Out (FIFO) system followed for use of chemicals / reagents / media?
• Are chemicals examined for proper labels and expiration date, if applicable, at the time of receipt?
• Are chemicals and reagents stored properly with different chemicals differentiation?
• Are working/reference standards stored properly?
• Are secondary or working reference standards calibrated against primary reference standards?
• Are lab reagent bottles properly labelled (like Name of reagent, date of preparation, use before date, prepared by, standardization factor, Code No., storage temperature)
• Is entry to microbiology laboratory restricted?
• Is there gowning / degowning procedure for entry and exit from the microbiology laboratory?
• Is the area monitored where microbiological testing performed?
• Are personnel working in microbiology lab examined for personal hygiene?
• Is there an SOP describing
• Preparation and usage of culture media?
• Discarding of used cultured media?
• If microbiological media is prepared internally, can these be tracked to respective preparation date, batch number and sterilizing cycles?
• Are the standard bacterial Cultures available?
• Is the bacterial passaging record available?
• Is there a SOP for cleaning and operation of LAF?
• Is LAF validated and re-validated as per a written protocol?
• Have sterilization cycles been validated for media preparation?

Please enclose list of following documents:

1. Organogram (with qualification, experience and job responsibilities of key personnel).
2. Copy of certificates of approval by State Authorities or any other approval.
3. List of Equipment’s/Instruments with make/model No. along with the mention of calibration of critical Analytical Instruments like HPLC, UV Spectrophotometer, Gas Chromatograph etc.

1. List of Working/Reference standards along with their source.
2. List of SOPs.
3. List of clients.

SPECIMEN SAMPLE FOR THE WRITTEN CONTRACT

1. The contract must establish a procedure through which the authorized person of contract laboratory must put into practice his/her responsibilities concerning the issuing of analysis certificates.

2. Contract giver shall provide all the documents or information, or reference related to the analysis of the product i.e. Specification and Standard Test Procedures (STPs) (if applicable) for all Raw Materials, Packaging Materials and Finished Products and any other type of sample.

(The contract acceptor shall strictly follow the above mentioned Specifications and STPs (if applicable). In case of any deviation from the written procedures, the contract acceptor shall seek written approval from Beta Drugs before implementation of any deviation).

3. The contract giver shall ensure that the contract acceptor is informed of any critical aspect associated with the product, assay, etc. that may affect the equipment, facility, personnel and other materials or other products.

4. The contract analytical laboratory shall have the required valid Accreditations/Regulatory Licenses.

5. Beta Drugs shall be responsible for providing all revised documents to the contract analytical laboratory and be responsible for their retrieval, if the documents are controlled. The Contract analytical laboratory shall be responsible for implementing the revised documents.

6. The contract analytical laboratory shall arrange all inputs including Equipment, Machines and Facilities as per the requirements of the respective Specs and STPs (if applicable).

7. The contract analytical laboratory shall maintain a high standard of GLP in the facility and systems.

8. On completion of analysis, the contract analytical laboratory shall send a written intimation along with a COA to QA Department of Beta Drugs.

9. The contract analytical laboratory shall maintain all the raw data, records, documents etc. pertaining to each sample analyzed.

10. In case of any deviation from the written procedures, the matter shall be immediately referred to Contract giver. Contract giver shall review and investigate the situation and shall provide the corrective and preventive action. The same shall be evaluated by the contract acceptor laboratory.

11. Contract giver shall audit the contract analytical laboratory facility and documents from time to time for GLP compliance with prior notice.

12. The contract acceptor cannot outsource the services specified in the contract giver’s evaluation and previous approval of such modification in the contract.

QUESTIONNAIRE FOR EVALUATION OF CALIBRATING AGENCY

Organization and Management

Is the Agency organized in such a way that confidence in its independence of judgement and integrity is maintained at all times?

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?

Does the Agency have a technical manager who has overall responsibility for the technical operations?

Does the Agency have a quality manager who has responsibility for the quality system and its implementation?

Is the quality system reviewed at least once a year by the management to ensure its continuing suitability and effectiveness?

Does agency procures outside services or supplies?

Does qualified person receive equipments?

Is any documentation or coding used to track equipment received for calibration?

Quality Control Manual

Does the Agency maintain a Quality Control Manual or any other appropriate system containing, as a minimum, the following:

1. a quality policy statement, including objectives and commitments, by top management,

1. the organization and management structure of the Agency,

1. the relationship between management, technical operations, support services and the quality system,
2. procedures for control and maintenance of documentation,

1. job descriptions of key staff and reference to the job descriptions of other staff,

1. identification of the Agency’s approved signatories,

1. 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,
2. reference to the test procedures used,

1. reference to procedures for calibration, verification and maintenance of equipment,

 list of codes and standards maintained for reference by the Agency, and procedures for audit and review?

Personnel

Does the Agency have sufficient personnel, with the necessary education, training, technical knowledge and experience for their assigned functions?

Are records on the relevant qualifications, training, skills and experience of the technical personnel maintained by the laboratory?

Is there a training program described in the Agency’s written practice?

Are eye examinations required for all inspection personnel?

Are outside agencies used for training and examining personnel?

Facilities and Equipment

• Are the facilities, equipment, instructions, and specifications adequate for the type of work to be performed?
• Are adequate procedures in effect to control the maintenance, calibration, and use of equipment including applicable tools, gauges, and other instrumentation?
• Is equipment (tools, gauges, and other instruments) identified to reflect:

1. Date last calibrated,
2. Date of next calibration, and
3.   Identification or serial number?

• Is the environmental condition of laboratory maintained and recorded?
• Equipments/Instruments available for testing (give list along with their manufacturers).
• Is there any schedule for performing calibration of equipments?
• Are internal standards used for calibration traceable to any National / International Accreditation Agency?
• Are there written procedures for operation and calibration of instruments?

Project Administration and Documentation Procedures

Are contract requirements reviewed to ensure specification compliance with applicable codes, standards and specifications?

Are inspection and test results documented and reported as required?

Are the results of each test, or series of tests, reported accurately, clearly, unambiguously and objectively?

Does the Agency have the ability to provide inspection services at offsite fabrication facilities?

Is there any instrumentation-training programme?

What is the proposed lead time for reporting of results/ dispatch of results?

Is there any preventive maintenance programme for instruments?

Are all data (final report and related raw data) reported to client?

Does agency retain records of original observation, derived data and test records?

Are records legible, readily retrievable and have a procedure for backup of records stored electronically?

Are all the tests being performed as per client’s requirements?

Are the testing reports signed and dated by analyst?

Are the testing records counter checked / signed by Incharge before dispatch of report?

Does the laboratory have procedures to control all documents forming part of quality system e.g. regulations, standards, test methods, specific instructions, etc.

Are all documents issued to personnel in laboratory, reviewed and approved by authorized personnel before issuing?

Are written procedures/test methods reviewed and updated?

Are written procedures for calibration of equipment’s if received from client properly documented?

Is there a protocol that requires the client to be notified of changes made to test procedures?

Is there any procedure for informing the client in case any equipment is failing in calibration and any remedial action that can be taken?

Please enclose list of following documents:

1. Organogram (with qualification, experience and job responsibilities of key personnel).
2. Copy of certificates of approval by State Authorities or any other approval.
3. List of Equipment’s/Instruments with make/model No. along with the mention of calibration of critical Instruments
4. List of Master/standard equipment’s used along with their source.
5. List of SOPs.
6. List of clients.