Out side analytical lab approval

GOOD MANUFACTURING PRACTICE (cGMP) QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000
1

Hai to all,
i am new to this knowledge park.i want details about how we approve the outside lab for approval.i need checklist also.and after approvalhow we inspect that labarotory.
thanking u.

srinivas.g

2

Thats a very big question,

Could you be more specific?

3

Dear sir,
actually in our firm some analytical parameters are analysed at some analytical laboratory.i want to make a audit to that lab for that i need a checklist.please.
thank u
srinivas.g

4

Dear
If u r aquiring some other lab fascilities for testing your products. then the audit scope shud b limited to that product testing. I mean u have to audit Instrument qualification, Instrument log book, Method validation, Reagent and chemiclas quality, Trainig of analyst, log books and analytical records etc etc.

Regards,
Shahid Ali
QA Manager
APF SC, Ethiopia

5

The following pionts should be consider during auditing the lab

[LIST=1]

  • Written and approved SOPs for all manufacturing and
  • testing activities.
  • Regular review of SOPs.
  • Revisions to SOPs approved by an authorized person.
  • System of distribution and control of SOPs.
  • Validation and revalidation of all equipment.
  • Calibration of all instruments.
  • Reporting, investigating and recording all deviations.
  • Frequency of environmental monitoring.
  • Quarantine and release systems.
  • Reprocessing of unsatisfactory and returned products.
  • Evaluation and investigation of complaints.
  • Recall of products.
  • SOPs for all QC laboratory operations.
  • Independence from QC department.
  • Self-inspection of each manufacturing and test area.
  • Inspection follow-up to ensure action is taken.
  • Follow-up of national control authority’s inspection and
  • recommendations.

    Quality Control:

    Does the quality control unit have adequate laboratory space and equipment?
    Are written calibration procedures available for instruments.
    Specification, standards, sampling plans. Test procedure and other laboratory control mechanism

    Any change reviewed and approved by Q.A
    Laboratory control established to ensure tested materials confirm to appropriate standards of identity, strength, quality and purity (Q.C. Protocols)
    These labs. Control include all required testing and documentation
    Reagent culture media, labeled and preparation recorded in lab. book with expiry date.
    Written sampling and testing plan for raw materials intermediate and final product and precise criteria for release.
    Description of sampling and testing procedure for in-process material
    Retest policy and criteria for retest, No. of samples and documentation required.
    All reference reagents kept secure properly stored identified and their integrity maintain.
    All retention samples, of each lot of final product stored under conditions consistent with product labeling?
    Quarantine and release system
    Evaluation and investigation of complaints.
    Recall of products.
    Q.C. involved in decisions pertaining to product quality is Q.C. monitor consistency of productions.
    Separate laboratory for microbiology and sterility testing.
    Animal test performed.
    Animal house maintained.
    Lab. Sufficiently equipped with suitable instruments/ equipments
    Separate laboratory for bacterial and viral vaccine test.
    Proper, clean and adequate facilities available for:
    area.
    clean towels
    Retiring/Dining rooms

    • 6

    The following pionts should be consider during auditing the lab

    [LIST=1]

  • Written and approved SOPs for all manufacturing and
  • testing activities.
  • Regular review of SOPs.
  • Revisions to SOPs approved by an authorized person.
  • System of distribution and control of SOPs.
  • Validation and revalidation of all equipment.
  • Calibration of all instruments.
  • Reporting, investigating and recording all deviations.
  • Frequency of environmental monitoring.
  • Quarantine and release systems.
  • Reprocessing of unsatisfactory and returned products.
  • Evaluation and investigation of complaints.
  • Recall of products.
  • SOPs for all QC laboratory operations.
  • Independence from QC department.
  • Self-inspection of each manufacturing and test area.
  • Inspection follow-up to ensure action is taken.
  • Follow-up of national control authority’s inspection and
  • recommendations.
  • Does the quality control unit have adequate laboratory space and equipment?
  • Are written calibration procedures available for instruments.
  • Specification, standards, sampling plans. Test procedure and other laboratory control mechanism
  • Any change reviewed and approved by Q.A
  • Laboratory control established to ensure tested materials confirm to appropriate standards of identity, strength, quality and purity (Q.C. Protocols)
  • These labs. Control include all required testing and documentation
  • Reagent culture media, labeled and preparation recorded in lab. book with expiry date.
  • Written sampling and testing plan for raw materials intermediate and final product and precise criteria for release.
  • Description of sampling and testing procedure for in-process material
  • Retest policy and criteria for retest, No. of samples and documentation required.
  • All reference reagents kept secure properly stored identified and their integrity maintain.
  • All retention samples, of each lot of final product stored under conditions consistent with product labeling?
  • Quarantine and release system
  • Evaluation and investigation of complaints.
  • Recall of products.
  • Q.C. involved in decisions pertaining to product quality is Q.C. monitor consistency of productions.
  • Separate laboratory for microbiology and sterility testing.
    • 7

    [quote=srinivas2202]Dear sir,
    actually in our firm some analytical parameters are analysed at some analytical laboratory.i want to make a audit to that lab for that i need a checklist.please.
    thank u
    srinivas.g[/quote]

    I think shahnawaz u have provided a very comprehensive list to conduct a full length audit, by the way this guy needs the information to audit a lab there they are using some lab fascility for some testing parameters.

    Regards,
    Shahid Ali
    QA Manager
    APF SC, Ethiopia

    8

    Excellent post Shahnawaz

    9

    thanks for u r reply