What are 5 regulatory authorities?
FDA, HSA, AVA, EMEA (European Medicine Evaluation Agency), MCC (Medicine control council).
What are the role of regulatory authorities?
Regulate the pharmaceutical industry from initial drug product development to routine manufacture.
What are GMPs, and what do they ensure and require?
GMPs are an international set of regulations that ensures all products are safe, pure and effective by requiring all manufacturers to comply and perform according to GMP regulations.
How do GMPs protect consumers?
They help companies to minimize or eliminate contamination, mixups or errors, which protects consumers from purchasing products that are not effective or dangerous
How does GMP make good business sense?
Decrease in product failures More efficient and reproducible process Equipment well maintained Recalls and complaints decrease Safe and high quality products are achieved
What is the specificity of GMP regulations?
Very general and open minded
Manufacturer can decide individually how to implement
Allows flexibility
Interpretation must make sense to manufacturers
What are common GMPs that are required in different countries?
SOPs
Independent QC and QC units
Equipment and facilities being properly designed, cleaned and maintained
Well trained personnel and management
What are 3 examples of global/ international GMPs?
PIC/S - Pharmaceutical Inspection Co-operation Scheme)
Singapore: HSA - Centre for Drug Administration
WHO TRS - Technical Report Series, for use mostly in developing countries
Which drugs have to comply with USA GMPs?
All drugs manufactured in the USA and introduced to interstate commerce
All drugs exported to other countries
All drugs imported into USA
FDA has authority to deny entry to any drug if there are questions about its safety and purity
What are Universal GMPs?
They are different regulatory agencies around the world harmonising at a common set of requirements
International Conference on Harmonization is a group of experts from EU, Japan and US working together
What are the methods to keep track of changes in GMPs?
Changes are communicated by presentation and papers presented by the FDA personnel, and through agency guidelines
A way to keep track of changes is to watch recent FDA-483 letters, or warning letters issued to firms
What are international pharmacopoeias?
The role of pharmacopoeias is to furnish quality specifications for drug substances and general requirements for dosage forms. They are intended to achieve a possibly wide global uniformity of quality specifications.
What items are adulterated, and how are these items adulterated?
Products not following cGMPs are adulterated.
Firms can take “voluntary actions”
FDA can take “regulatory actions” if firms are non-compliant
What is the list of 9 actions that can be taken in order?
- FDA 483
- Recalls and request testing of critical products
- Warning letters
- Import alerts (Border alerts)
- License suspension or Revocation
- Seizure
- Consent Decree
- Criminal prosecution
- Jail time
What are inspections, how and where are they conducted in US context?
FDA evaluating conformance of drugs to cGMPs, by testing samples from retail stores or firms, or by conducting periodic inspections of facilities.
Inspections are conducted at firms both in the US, and overseas firms that export to the US
What is a FDA 483, and how should companies respond?
It is a form used by inspectors to record observations of non compliance with cGMPs.
Firms are not required to respond, but considered prudent to do so.
Tell the FDA what will be done to correct not just the immediate or specific problem, but the system that is the root of the problem.
What is a FDA 484
Receipt for samples obtained during inspection
What are recalls?
Recalls are voluntary actions made by firms to remove their products from the market.
FDA cannot recall drugs, but can suggest to firms to take action on violative products
What is a warning letter?
A warning letter is a communication to the firm, stating to the firm their products are adulterated.
The firm has limited amount of time to respond before FDA takes further regulatory actions
What are import alerts?
Import alerts block product’s entry into the US if they are found to not comply with regulations.
What are seizures?
Seizures are made if they are in imminent public health threat, or if the firm has not satisfactorily complied with FDA requirements
They are approved by federal court judges, and US marshals accompany the FDA during the seizure.
What are consent decrees, and in what situations are they given out?
They consists of fines, reimbursement to government for inspection costs, or penalties for non compliance.
They are given out if the firm has repeatedly violated cGMP requirements, and they are enforced by federal courts.
They are usually permanent, but if the firm has achieved compliance, it can petition the court to remove the consent decree
What is license suspension or revocation
FDA can temporarily suspend or permanently revoke license if the firm does not comply with cGMPs
What is criminal prosecution?
In cases usually involving fraud, FDA and prosecutors will file criminal charges. If found guilty, the person is subject to fines and imprisonment
