CGMP chapt 2

singapore authorities

• HSA

• AVA

HSA

• pre and post market drug testing

• work towards international harmonization

AVA

• animal vaccines

• food safety

• GLP/GMP

GMP

• makes sure all products are safe, pure and effective

• all manufacturers are required to comply with GMP regulation

• GMP is an international set of regulation

how ere GMPs developed?

• started based on best practices of industry

• as practices and tech improved, GMP evolved

• building in quality rather than testing the quality

how does GMP protect consumer?

• minimizes

  • contamination

  • mixups

  • errors

GMP makes good business sense

• product failure decrease

• process more reproducible

• equipment well maintained

• recalls and complaints decrease

• all in all safe and quality product achieved

are GMP regulation specific?

• HELL NAWW NIGAA

• very general and open-ended

• let manufacture decide

Global International GMPs

• world health organization (WHO)

• PIC/S (pharmaceutical inspection Co-operation scheme)

• Australia: (therapeutic goods administration)

• Singapore: Health science authority (center for drug administration)

USA GMPS

• Published by FDA under the Federal Food, Drug, and Cosmetic Act (FD&C).

• Regulations have the force for of law

• Requires products are safe, pure, and effective through proactive measures.

USA GMP 21 CFR covers?

• human & veterinary products

• medical devices

• processed food

• blood

• blood components

why US regulation are called “current”

emphasize that the expectations are changing all the time

which drug have to comply with USA GMP

• all drugs manufactured, sold, exported and imported in/to US

• FDA has the authority to deny entry to any drug.

Europe GMP

• Based on Directive 91/356/EEC (amended by 2003/94/EC for human use and 91/412/EEC for veterinary)

• Each Article forms a complete chapter in EU Guide to GMP for Medicinal Products

universal GMP

• Regulatory agencies worldwide align on common requirements.

• ICH (International Conference on Harmonization): Collaboration between EU, Japan, and U.S. to standardize guidelines.

changes in GMP

• in US, Through FDA presentations, papers, and agency Guides and Guidelines.

• keep track of FDA-483 and warning letters

International Pharmacopoeias

A pharmacopoeia is an official reference book containing standards for the quality, purity, and preparation of medicines.

what type of product must follow cgmp

All products -- prescription and over-the-counter (OTC) -- available for use in the U.S.A.

adulteration

• products not made according to cGMPs are adulterated

• subjected to voluntary actions by firms or regulatory action by FDA against noncompliance people

list of voluntary and regulatory action

• FDA 483

• recalls and new testing of critical product

• warning letters

• import alerts

• license suspension

• seizure

• consent decree

• criminal prosecution

• jail time

inspections

• inspection of facilities

• testing samples

• conducted at firms in the US and overseas firms that sells product in the US

definitions

• IOM - Investigation Operations Manual

• FDA 482 - notice of Inspection

• FDA 483 - Inspectional observations

• FDA 484 - receipt for samples obtained during inspection

• EIR- report explaining observations of FDA

IOM

US FDA regulatory affairs inspectional reference

FDA 482

form by FDA inspector prior to an ainspection

FDA 483

• used by inspector to record their observations of non-compliance with cGMPs

• firms not required to respond, but considered prudent to do so.

• firms would tell FDA the process to correct immediate issues and prevent future problems by addressing the root causes.

Consent Decree

• A legal agreement between the FDA and a firm for repeated cGMP violations.

• Enforced by federal courts, often including fines, inspection cost reimbursements, and compliance deadlines.

• Usually permanent, but can be removed if the firm achieves compliance and petitions the court.

recalls

• voluntary actions made by firm to remove product from market

• FDA cannot recall drug but they can suggest the firm to take actions on violative product

warning letter

• communication to the firm

• generally states the firm made adulterated products

• firm given limited amount of time to address the issue before FDA take further actions

seizure

• A legal action taken when there's an imminent public health threat or if a manufacturer fails to correct issues.

• Approved by a U.S. Federal Court judge, with U.S. Marshals assisting the FDA.

• Aimed at drawing attention to non-compliance by senior management.

import alerts

• for drug products made outside the US

• FDA issue import alert that require US customs to block product entry into US

license suspension or revocation

FDA temporarily suspend or permanently revoke a license if cGMPs not complied

criminal prosecution

• cases involving fraud FDA and federal prosecutors will file criminal charges

• results in fines and imprisonment if found guilty

FDA information sauces

press release, FDA news and talk papers

type of FDA information

• approvals

• reacalls

• alerts

• warnings

• health advisory

inspections

• drug inspection program

• biologics inspection programs