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?
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