Facts about the cGMP AUDITS AND COMPLIANCE?
• cGMP stands for Current Good Manufacturing Practice regulation enforced by the US Food and Drug Administration (FDA). India has become a priority location for the USFDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US. India with its Rs.1.1 trillion drug industry, which largely makes generics, exported around Rs.50, 000 crore of drugs in 2016-2017.
• USFDA has increased the number of inspections at FDA approved units. The number of FDA 483 and warning letters, import alerts issued to pharmaceutical companies globally, have risen over the years and have been asked to review and strengthen its CAPA (Corrective Action Preventive Action) practices.
Why Audits observation CAPA?
• CAPA: CAPA stand for Corrective and Preventive Action. FDA and regulatory agencies are looking closely in how Pharmaceutical companies conduct their investigations, and CAPA is viewed as the central component of Quality Management Systems. Corrective and Preventive Action (CAPA) is a key part of any Pharmaceutical quality program, and yet many companies continue to do it wrong (If FDA 483 and Warning Letter reports are any indicators). CGMPs provide the process that assure proper design, analysis, monitoring, and control of manufacturing processes and facilities. The purpose of your internal audits should be to deliver some kind of value to your business.
• GMP Quality System: This is a process of assessing Quality System components, such as trend analysis, internal SOPs, Controlling change, specifications, input inspection, personnel development and Outsourced operation control. Assess CAPA (Corrective and preventive action) programs.
How does FDA determine if a company is complying with cGMP regulations?
• FDA (Food and Drug Administration) inspects pharmaceutical manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are conducted by highly trained and experienced FDA staff. FDA also analyze reports of potentially defective drug products from the public and the industry. At the end of inspection FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the CGMP regulations.
Are Drug products safe for use if manufacturer is not following CGMPs?
• According to the rule of any cGMP if the company is not complying with CGMP regulations, any drug it manufactured is considered “adulterated” under the law. That is the drug is not manufactured under conditions that comply with CGMP.
• If the consumer currently taking medicines from a company that was not following CGMPs, FDA usually advises these consumers not to interrupt their drug therapy which could have serious implication for their health.
• Every new drug company should learn about cGMPs and about FDA’s expectations on complying with them.
Why should we attend workshops and Training conducted by consultants?
• Inspection Compliance process deficiencies have long been the number one Good Manufacturing Practice (GMP) violation cited in FDA 483's and Warning Letters for pharmaceutical companies.
• The reason Audit observation CAPA has not been effective is because CAPA practices have not become a culture and not percolated to the operator or plant level people. This workshop will focus on how to face a Audit and its compliance through a CAPA culture can be created in a systematic manner, so that CAPA is practiced not only in document but also in spirit of the organization.
1) How to address Audit notice, and How to face Audit
2) Fundamentals of Global cGMP Requirements-
Trends in cGMP Compliance
3) Triggering of CAPA from Audit observations
4) How to implement effective CAPA Systems- Effective CAPA Management for Optimal Compliance
5) Laboratory Compliance –Recent audit observations
and its CAPA.
6) CAPA- Failure Investigation and Root cause
7) Compliance Aspects of APIs Manufacturing
8) Compliance Aspects of Formulations
9) Compliance Aspects of Laboratory Quality
10) Compliance Aspects of Sterile Manufacturing
11) CAPA- Closure
12) Spotting Overall Weak GMP Compliance
13) Avoiding FDA Enforcement Actions: An
Optimal and Sustainable Compliance Program
14) Behavioural GMPS (bGxP®): A New Paradigm
in Compliance Management
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