SOP for Qualification of external service provider agency.
This Document describes (Standard Operating procedure) SOP for Qualification of external service provider agency.
SOP for Qualification of external service provider agency.
I. Purpose & Scope:
- The purpose of this SOP for Qualification of external service provider agency.
- This Standard operating procedure shall be applicable for Qualification of External Service Provider Agency on Calibration, Validation & External Laboratory for testing of samples.
II. Responsibilities:
- All Quality Assurance personnel shall be responsible to follow and implement this SOP.
III : Introduction and Procedural Part:
Procedural Part for Qualification of external service provider agency :
Selection of Contract Testing Laboratory:
- Quality assurance designee shall provide the Questionnaire as per annexure-I if the external contract laboratory is required to be newly introduced and for other external service provider Questionnaire as per annexure-VI.
- On identification, the assessment of the technical capabilities of the contract testing laboratories shall be done based on the following documentations received from the testing laboratories or from the authorized websites.
- Company / Laboratory profile.
- List of key personnel and their experience.
- Services provided & testing facilities.
- Upon satisfactory evaluation like NABL accreditation or approved from any foreign agency like USFDA, then on the basis of accreditation, the laboratory can be audited for a day to evaluate the system to include as part of approved external vendor.
- The audit of contract analytical laboratory shall be done by Head Quality with technical team.
- Head quality with Technical team shall audit the External Service provider Agency as on predefined scheduled date and issue the audit report within 15 days from the date of audit to the External Service provider Agency as per Annexure II.
The Audit shall be in accordance to predetermined check list for qualification of external service provider agency.The check list shall include but not limited to :
- Organogram / job responsibility.
- List of instrument and equipment to be used for the analysis.
- Document & Data control for traceability and secrecy.
- Handling of planned/unplanned deviation.
- Procedure for sample management and destruction.
- Change Control Process.
- Out of specification SOP and Record.
- Self-Training.
- Control Sample Management.
- FDA Approval and license for testing.
- Validation/ Qualification / Calibration of equipment /instrument/Utilities.
- Annual Maintenance Contract for instrument and equipment.
- Traceability of master calibrator to national standards.
- Entry / Exit Procedure.
- Management of reagents and Volumetric Solution.
- Management of Reference Standards and working standards.
- Standard operating procedure(s).
- Management / Maintenance of logbook / registers.
- Environmental monitoring like temperature, humidity and differential Pressure (if applicable).
- Adequacy of premises and equipment knowledge and experience and competent personnel to carry out satisfactory analysis.
- Safety policy, measure and procedures.
- Cleaning and sanitization procedure.
- Sampling and analytical procedures.
- Analyst Certification.
- Verification of certificates of regulatory Approvals.
- Head QA and Audit team shall summarize the report including Approvals, Strength and documents reviewed during audit and prepare the report by categorizing the audit observation as critical, major and others and ensure the Compliance of the audit observations.
- Compliance report shall be received within 30 days from the receipt of the audit report from external service provider.
- After receipt of Compliance Report from External Service provider Agency, verification shall be done and approved by the quality head.
- Technical Agreement shall be proposed for consideration of Approved External Service provider Agency as per annexure-III.
- After receipt of filled and signed Technical Agreement template by External Service Provider Agency, the same shall be verified and reviewed by our technical team in presence of Head QA.
- If any amendment is to be added to the Technical Agreement, it shall be authorized by both the Contract giver as well as Contract acceptor. The agreement shall be authorized by any of the following :
- Head Quality
- Head Technical
- Director/CEO
- The amended copy of the Technical Agreement and Contract shall be also sent to Contract acceptor for Acknowledgement.
- The Audit team shall audit the analytical laboratory.
- Audit shall be focused to cover the retirements of samples to be sent and analysis to be performed to the laboratory.
The contents of technical agreements of Contract laboratory shall include but not limited to:
- Quality Assurance designee shall be providing relevant specification, standards operating procedures, Method of Analysis, Analytical method validation protocols and other technical information required for the sample analysis.
- The Laboratory shall follow the specification, standard operating procedures, method of analysis Analytical validation protocol as is without any change or modification.
- The Laboratory shall be responsible for Procurements of the requirements reagents/ Material from their approved vendors.
- The laboratory shall perform testing and release of the material as per customer Specification.
- The Laboratory shall ensure that all raw data observation and results delivered Comply with the specification and shall be reviewed and released by competent Authority. The Laboratory shall be responsible for implementing revised test specification or method of Analysis as per the updates communicated by the Head QA.
- Any Deviation from the specification & Method of Analysis provided by Head QA Shall require to the Authorized by Head QA prior to carrying out the deviation.
- Any out of Specification (OOS) reported during Analysis shall immediately be intimated to Head QA. Decision for Approvals /rejection shall be based on Joint OOS investigation by the contract laboratory.
- The Reference Standards/ Working standards shall meet Pharmacopeia.
- The laboratory informs Head QA in case of out of specification result and investigation / joint analysis shall be performed as defined in Quality system.
- The raw data (HPLC: System suitability, Standards and chromatograms, Weight taken etc.) along with certificate of analysis (COA) shall be provided by laboratory to customer within the stipulated time frame.
- The Laboratory shall not pass samples to third party (subcontractor) for analysis without prior to evaluation and Approvals from customer. If subcontract available, customer shall audit the subcontract facility for its adequacy and requirement of GMP/GLP/GDP.
- External testing laboratory shall provide all the details of approved subcontractor such as audit report, technical agreement etc., to customer
- External testing laboratory shall be permitted to customer for audit of its approved testing subcontractor.
- The Laboratory shall refrain from any activity, which may adversely affect the quality of product, analyzed for the customer if the event of any complaint/product quality problem, all the investigation records to access the quality of product, shall be accessible to customer.
- At all time the laboratory shall maintain and update the cGMP and compliance. The laboratory shall know that it is subjected to the inspection by the competent Authorities at any point of time with or without prior notice.
- All information supplied by either party must be kept confidential and may not be disclosed to any other party without express permission of counterpart.
- Head – Quality Assurance shall be responsible for renewal, Up-gradation and cancellation of service contract.
- The Renewal of contract shall be only through the Audit & Approval procedure mentioned as above.
- The Audit report of the laboratory can be used by customer. However they shall ensure the availability of equipment’s / testing facility, competency of analyzing their samples or Specific tests of the samples.
- Samples for the regulatory submission to be sent to the laboratory shall be through sample request for regulatory submission by quality control.
- Result of a test from contract laboratory shall be communicated in writing .No verbal Communication shall be used for the releasing the Raw material, Packing material and drug product.
- The technical agreement shall be valid for two year from last authorized signature.
Frequency of Audit for qualification of external service provider agency:
- The contract analytical laboratory reassessment audit shall be done once in 2 years + 30 days.
- As and when required for investigation.
IV : ANNEXURE:
| Annexure | Format Name |
| Annexure – I | Contract Testing Laboratory: Questionnaire |
| Annexure – II | Audit Report |
Annexure I
CONTRACT TESTING LABORATORY- QUESTIONNARIE
| A) General Information on Analytical Laboratory and Quality Management
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| 1. Contract Testing Laboratory Information | |||
| 1.1 Contract Testing Laboratory Address Information | |||
| Name of Contract testing laboratory: | |||
| Address: | |||
| Postcode: | |||
| City: | |||
| Telephone number: | |||
| Fax number: | |||
| Web address: | |||
| 1.2 Is the address listed above the only site for testing? | Yes No | If NO, please provide details below | |
| Name of contract testing laboratory: | |||
| Address: | |||
| Postcode: | |||
| Telephone Number: | |||
| Fax Number: | |||
| 1.3 Is your contract testing laboratory a subsidiary/Subcontractor? | Yes No | If YES, please provide details below | |
| Name of Contract testing Laboratory: | |||
| Address: | |||
| Postcode: | |||
| Telephone number: | |||
| Fax Number: | |||
| 1.4 Contract Information (Please provide details of an available contact) | |||
| Name: | |||
| Position: | |||
| Telephone Number: | |||
| Fax Number: | |||
| Email address: | |||
| 1.5 Site Personnel Information | |||
| Approximate total number of employees at testing facility of interest: | |||
| Approximate number of employees in the Quality Unit (Quality Assurance/ Quality Control) | |||
| Approximate number of employees in Testing Operations Unit | |||
| If available, please enclose a copy of your Organizational chart indicating key personnel. | Enclosed Ref:
|
N/A | |
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Does your laboratory operate in a shift system? How many? How many days a week? |
Yes No | ||
|
1.6 Contract Testing Laboratory structure |
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| What is the legal ownership structure of your Contract Testing Laboratory? | |||
| Please give a brief structure-diagram |
Ref: |
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| Do you expect a change of the legal status and/or ownership of your Contract Testing Laboratory in the near future? | Yes No | ||
| Do you have an annual report available?
If yes, please enclose the annual report |
Yes No
Ref:
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| 2. Quality Standards and Certifications. | ||
| Do you hold certification(s) against any recognized quality standards by a accredited third part body e.g. ISO & other competent authority? If yes, please provide a copy of certificate(s) | Yes Ref. No N/A | |
| Do you hold accreditation, certificate or registration by any regulatory agency or body? If yes, please provide a copy of documentation | Yes Ref. No N/A | |
| Are any aspects of the process/ service provided subcontracted? | Yes No N/A | |
| If so, please provide details: | ||
| Are there Quality/ Technical Agreements held with subcontractors? | Yes No N/A | |
| 3. Quality Management Documentation | |||
| Do you have procedures that document how you perform the following activities:
If ‘YES’ please provide the document reference number/ identification. |
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| 3.1 | QUALITY SYSTEM | Comment | |
| 3.1.1 | Quality Policy/Manual | Yes No N/A | |
| 3.1.2 | Equipment & Instrument Validation/ Qualification Program | Yes No N/A | |
| 3.1.3 | Internal Audit/Self Inspection Program | Yes No N/A | |
| 3.1.4 | Analytical Laboratory
Evaluation/Qualification Program |
Yes No N/A | |
| 3.1.5 | Does your Contract Testing Laboratory operate a supplier- auditing system? | Yes No N/A | |
| 3.1.6 | Training Program | Yes No N/A | |
| 3.1.7 | Change Control | Yes No N/A | |
| 3.1.8 | Deviation/Investigation Reporting | Yes No N/A | |
| 3.1.9 | Non-Conformance Reporting | Yes No N/A | |
| 3.1.10 | Documentation Control | Yes No N/A | |
| 3.2 | FACILITIES AND EQUIPMENT SYSTEM | ||
| 3.2.1 | Pest Control Program | Yes No N/A | |
| 3.2.2 | Preventive Maintenance Program | Yes No N/A | |
| 3.2.3 | Calibration Program | Yes No N/A | |
| 3.2.4 | Facility Cleaning / Sanitization | Yes No N/A | |
| 3.3 | LABORATORY CONTROL SYSTEM | ||
| 3.3.1 | Method Qualification for all assays used in Testing of Samples | Yes No N/A | |
| 3.3.2 | Testing Reagents and Standards Controls Policy/ Procedure | Yes No N/A | |
| 3.3.3 | Sample Retention Program | Yes No N/A | |
| 3.3.4 | Out of Specification (OOS) / Retest Procedures | Yes No N/A | |
| 3.3.5 | Availability of Analytical Raw Data Documentation | Yes No N/A | |
| 3.3.6 | Whether QC carries out its own physical-chemical testing, biological testing, microbiological testing and sterility testing and instrumental testing. | Yes No N/A | |
| 3.3.7 | Please specify the arrangement provided for handling and storage of test samples, retained samples, reference standards/ cultures, reagents. | Yes No N/A | |
| 3.3.8 | Whether separate area for storage of reagents and glassware’s provided. | Yes No N/A | |
| 3.3.9 | Whether separate record room is provided. | Yes No N/A | |
| 3.3.10 | How hazardous or poisonous materials are stored and handled? | Yes No N/A | |
| 3.3.11 | How environmental conditions are met during the course of storage and testing of samples. | Yes No N/A | |
| 3.3.12 | Whether separate washing and drying area are provided | Yes No N/A | |
| 3.3.13 | Which grade of glassware are used in assay procedures | Yes No N/A | |
| 3.3.14 | Whether separate AHU’s are provided for biological, microbiological and radio isotopes testing areas with HEPA filter arrangement. | Yes No N/A | |
| 3.3.15 | Whether separate areas are provided for sterility testing within microbiology laboratory | Yes No N/A | |
| 3.3.16 | Whether support areas are under AHU | Yes No N/A | |
| 3.3.17 | Whether double door autoclave provided for sterilization of materials | Yes No N/A | |
| 3.3.18 | Whether double door autoclave provided for sterilization of materials. | Yes No N/A | |
| 3.3.19 | Whether entry to the sterility area is through three air lock systems. | Yes No N/A | |
| 3.3.20 | What is the air class of these testing area and whether pressure difference is maintained in these areas | Yes No N/A | |
| 3.3.21 | When was the last filter integrity tests performed on HEPA filters | Yes No N/A | |
| 3.3.22 | How waste (cultures, etc) disposed off. | Yes No N/A | |
| 3.3.23 | Whether in case of antibiotic potency testing, statistical proof of the determination of potency and validity of the test carried out. | Yes No N/A |
| 4. Comments :
|
| Completion Signatures
· Confirmation that enclosed information is correct and relevant to the testing of samples in scope. · You will inform us in case of any changes to the testing status. |
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Site Operations Lead Representative
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| Name:
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| Position:
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| Signature /Date : |
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| Head of Quality Assurance or representative; person who completed the questionnaire: | |
| Name:
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| Position:
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| Signature /Date : | |
Annexure II
AUDIT REPORT
- A) GENERAL INFORMATION
| SITE
ADDRESS PHONE FAX |
|
| TYPE OF OPERATION
TYPE OF PRODUCTS PRODUCT FORMS MARKET |
|
| PRIMARY ESCORTS | |
| AUDIT TEAM | |
| OTHER PARTICIPANT AUDITEES | |
| DATE OF AUDIT |
- B) SUMMARY
General Information about the Company & Site
- C) GMP INSPECTION REPORT
| Sr. No. | Area/ Observation Made | Category* | Action Plan |
* Write as applicable,
ASC: Area of special concern/ critical, MJ: Major, MN: Minor, CM: Comment
Note: Above GMP lapses are observed during our audit, kindly plan for CAPA to avoid the reoccurrence for the same & forward the compliance report with documentary evidences wherever applicable. If any clarification required please feel free to contact us.
Sign of Auditor: __________________ Approved By: __________________
Date: Date:
Name: Name:
Designation: Designation:
Head Quality Assurance
- D) GMP COMPLAINCE REPORT: (For customer QA only)
| Observation report
sent on |
CAPA received
on |
Verified by
(Sign and Date) |
Remarks |
|
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Conclusion:_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Sign of Auditor: __________________ Approved By: ______________
Date: Date:
Name: Name:
Designation: Designation:
Head Quality Assurance
