Compliance in an Outsource Manufacturing Model: What to Look For - Pharmaceutical Technology

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Compliance in an Outsource Manufacturing Model: What to Look For
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.

Pharmaceutical Technology

Atypical and OOS results

  • Is there a standard operating procedure (SOP) for investigation of out of specification (OOS) results?
  • Does it describe notification, investigations, product impact, corrective actions, trending, regulatory reporting?
  • Are investigations performed in a timely manner?
  • Are investigations thorough and complete?
  • Are corrective actions followed up in a timely manner?
  • Is there trending of discrepancies?

Documentation control and approval

  • Is all documentation associated with the routine testing approved?
  • Does the QA unit have an authorized person or department specifically charged with the responsibility of obtaining approval by signature/date for production and testing procedures, forms, and records?
  • Is there an SOP that defines the scope and roles and responsibilities for the document control and retention system?
  • Are all production and control records specifically associated with a batch maintained at least one year after the expiration date of the batch?
  • Is there a document control procedure that would prevent the use of invalid or obsolete documents?
  • Is there an SOP that addresses 21 CFR Part 11 issues?

Change control

  • Are there SOPs covering all elements of the change control process? Do change requests include description, requirements (e.g., revalidation), impact evaluation, and effective date designation?
  • Is change control documented, evaluated, and approved?
  • Is a procedure in place to ensure that personnel are trained on the changes in a timely manner?
  • Are customers notified of critical changes?
  • Review some change requests and ensure that they are implemented according to procedure.


  • Is there an SOP describing training?
  • Are personnel trained to perform their assigned tasks? By what method? Are training materials, including GMP training materials, available?
  • Indicate how on-going, periodic GMP training is accomplished, including training following an operator or analyst error.
  • Is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer?
  • Is there adequate staffing?

Internal quality and GMP audit program

  • Does a formal auditing function exist in the QA department?
  • Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits?
  • Does a written SOP specify the scope and frequency of audits and how such audits are to be documented?
  • Does a written SOP specify the distribution of the audit report?

Facility layout and design

  • Are there designated areas for raw materials, components, in-process materials, and packaging materials?
  • Is the facility temperature and humidity monitored?
  • Is there a designated area for sampling and dispensing of raw materials in a controlled environment to prevent contamination?
  • Are there designated processing areas with air monitored for temperature, humidity, and room differential pressures?
  • Is there sufficient space in the facility for the type of work and typical volume of production to prevent mix-ups?
  • Is there a written procedure for the prevention of infestation from rodents, birds, insects, and vermin? Is the facility free from infestation?
  • Is the facility maintained in a clean, well-maintained, and sanitary condition?
  • Does the facility have written procedures that sufficiently detail the cleaning schedule, methods, equipment and materials?
  • Are all parts of the facility maintained in a good state of repair?

Environmental control program

  • Is there a formal environmental monitoring system?
  • Is the facility not situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations?
  • Is the lighting adequate in all areas?
  • Is adequate ventilation provided?
  • Are hard smooth surfaces easily cleanable?
  • Is control of air pressure, dust, humidity and temperature adequate for the storage and testing of drug products?
  • Is there a written procedure specifying the frequency of inspection and replacement of HEPA filters?


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