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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.

Training

  • 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?


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here