Audits Flashcards
- What should be done when an entry is made at a time later than the activity was performed?
Clearly indicate the date the activity was performed and the date the activity is recorded on the documentation.
* Document an explanation to substantiate the entry and the reason for the delay in recording.
* Sign and date the change.
* Backdating of entries is not permitted.
How should one complete all fields on a record?
- All fields on a record should have an entry, even if it is ‘N/A’.
- Multiple blank spaces/rows/columns on a record must be marked out with a single line across the whole field/space.
- Marking out a larger space or whole page may be completed with a diagonal line.
- Sign and date to show that the field/space is not applicable.
How should corrections or amendments be checked after the content of the record has already been checked?
The correction must also be checked by the same person who checked the rest of the document.
How should record dates be formatted?
- Record dates following common practice of the country, such as Day/Month/Year (IRE) or Month/Day/Year (USA).
- Examples include 11/03/12 or 11/03/2012 or 11 Mar 2019 or 03 Nov 2019.
- Record time in 24 hour format (00.00 – 23.59).
- What is the issue with Schering Plough?
Schering Plough was audited by the FDA on several occasions and 483s were issued.
* Every time the FDA returned, none of the issues identified in the 483s had been addressed.
* The FDA took action against the company after inspectors found serious violations of CGMP regulations during 13 inspections at four New Jersey and Puerto Rico facilities since 1998.
What was the offense in US v Barr?
The offense was violating GMP for testing under the Federal Food, Drug and Cosmetic Act (the “Act”).
* Barr Laboratories routinely retested often entailing resampling and reprocessing.
* The court did not accept the FDA submission that an OSR necessarily meant a batch failure.
What did Judge Wolin prefer to use instead of “product failure”?
- Judge Wolin preferred to use the term “out-of-specification” (OOS) laboratory results rather than the term “product failure” which is more common to FDA’s investigators.
What are the lessons learned from the Baxter and Heparin case study?
- The Baxter Heparin supply accounts for about half of the U.S. supply and may result in a public health crisis resulting from heparin shortages.
- Both the FDA and Baxter are researching scientifically the cause of this contamination with capillary electrophoresis and magnetic.
What is the purpose of external audits related to Good Manufacturing Practice (GMP) regulations in the pharmaceutical industry?
- To verify compliance with GMP regulations
- To verify that manufacturing and control systems are operating under a state of control
- To permit timely correction of potential problems
- To show confidence to remain under an adequate level of GMP practice in Pharma
What are the types of quality audits? The quality audit system is mainly classified into three different categories:
- A company on its vendors or sub-contractors
- HPRA department of the company (depending on the country)
- Global Quality Assurance Group for cause & routine inspections
What are the benefits of audits in the pharmaceutical industry?
- Assuring GMP compliance
- Detecting potential problems
- Increasing management awareness
- Improving current systems
What are the types of deficiencies classified during audits?
- Critical: product quality/patient safety-related
- Major: significant cGMP deficiency but with no direct impact on product quality/patient safety
- Other GMP deficiencies that are either considered to be minor isolated examples or there is insufficient information to classify them as major and fully understand the evidence for the deficiencies.
What goes on in an audit in the pharmaceutical industry?
- Opening meeting
- During the audit: walk-through of the facility, assessment of cleanliness and condition of facilities, and recording of observations with supporting evidence
- Concerns are discussed with the auditee as they arise to avoid surprises in the closing meeting
- Closing meeting
What happens during the opening meeting of an audit?
- Introducing auditor(s) to relevant auditee staff and Senior Management Representative
- Agreeing on the audit rationale, plan, and communication channels
- Clarifying ambiguous replies in the pre-audit questionnaire
- Agreeing on the auditee’s rules concerning safety, taking photographs, confidentiality of information, taking samples, talking with operators, making recordings, etc.
What happens during the closing meeting of an audit?
- Review of the final reports and determination of what steps need to be taken to eliminate deficiencies
- Sincere encouragement of detection of problems and appreciation for being able to improve quality operations
- Sharing audit reports with manager supervisors who may discuss findings with employees
- Workers and supervisory personnel should be given feedback on their performance during the audit
