The Most Important Compliance Best Practices You Need to Know

CGMP controlled Raw Materials – Regulations and Best Practices

5155 Firms received FDA 483 between 10/1/2016 and 9/30/2017. One of the major reasons for issuing these FDAs was non-compliance with the regulatory requirements of cGMP controlled raw materials.  It is critical for personnel in the Pharmaceutical, Biotechnology, and Medical Device Industries to understand the regulatory requirements and best practices pertaining to cGMP controlled raw materials to gain approvals and make products safe for use.

Current Good Manufacturing Practices are regulations published by FDA to provide criteria for complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act). cGMP requires all drug products that are developed and produced are safe, properly identified, of the correct quality, strength, and purity. The word “current” is used in conjunction with GMP as technologies are constantly evolving and so do the requirements to attain GMP compliance. Even though cGMP regulations have been in place since long time, the large number of 483's and warning letters demonstrate that companies have problems with implementation. The GMP regulations are codified in 21 CFR 210-211.

A recent study showed that US consumers spent USD 23 billion on OTC drugs in 2010. The huge market for these drugs spurs companies to create and launch more products. The market growth has, however, also forced the FDA to crack the whip on regulatory violations. While a number of manufacturers of OTC drugs are warned for CGMP violations, many also face enforcement action for shoddy labeling and branding. Considering that consumer trust is vital for the sales of an OTC drug, news that a manufacturer has been fined or warned for mislabeling can lead to a significant drop in consumer confidence, affecting the company bottom line. This White Paper explains six best practices that manufacturers can follow to ensure that they comply with the FDA’s stringent OTC drug and drug-cosmetic labeling regulations.

Drug Enforcement Administration (DEA) audits are primarily carried out to ensure that there is no diversion or misuse of controlled substances.The audits also help to educate registrants in case of any identified discrepancies.This white paper addresses compliance issues relating to DEA audits, provides assistance to registrants to ensure strict compliance and the right adoption of drug ordering practices. It also details the correct ways to interact with inspectors during a DEA audit.

The FDA has strengthened its scrutiny of animal drug products as public awareness of the issues surrounding their use and adverse events have increased. A number of manufacturers have been warned about marketing products with treatment claims without first obtaining approval from the agency. The approval process for a veterinary drug is as complicated and rigorously analyzed by the FDA as the one for human medicines. This White Paper details what is considered an animal drug, the different types of applications and finally explains five best practices that manufacturers can adopt in order to ensure better compliance with the application process for a new animal drug.

In this article, Mithun Raja B. and Raghavendra Rao K., explain the clinical and regulatory requirements governing the process of prescription to OTC switches in USA and India. The article discusses the reasons for these switches, the process itself and what regulatory agencies in both countries require from pharmaceutical manufacturers.

In this article, Melvin Dionne, a pharmacist-consultant, provides a high level overview of Canadian regulations governing the licensing and manufacturing of natural health products.

In this article, Dr Uday Shetty, founder and Executive Director of Drug Regulations, a non-profit organization, provides insight into the recent Indian Supreme Court's decision on the Novartis cancer drug Gleevac and explains the reasoning behind the court's ruling on not granting a patent for the product.

In this article, Dr Uday Shetty, founder and Executive Director of Drug Regulations, a non-profit organization, discusses the recently issued Indian guidelines for Certifications of API exports to the EU and asks whether these will satisfy the EU's stringent requirements.

Canada is one of the few countries worldwide that has introduced and successfully implemented a regulatory framework for governing the sale and importation of natural health products (NHPs) to consumers. While the initial phase-in was met with disappointing review times and industry confusion over application requirements, the approval process has now become extremely efficient, with some types of NHP applications being approved in as little as 60 days. Sponsors wishing to receive product licences for their NHPs need simply to submit complete applications in proper format, and respond to any information requests within the given deadlines, in order to successfully register their products for sale in Canada.

GlaxoSmithKline, the British drug maker agreed to pay $3 Billion in fines for promoting its best-selling drugs for unapproved uses and failing to report safety data. The company also faces criminal charges and civic penalties for improper marketing of a half-dozen other drugs and for violating the government's Medicaid program. The fraud settlement includes $1bn in criminal fines and $2bn in civil fines.

This article explains 11 important questions arising from the fraud settlement by GSK.

Annual Product Review (APR) - Product Quality Review (PQR) reports are the first documents reviewed by health authorities while inspecting a manufacturing facility. The importance of this report is such that even a small error in reported data may have severe impact on product quality and patient safety. Considering its criticality and importance, organizations must try to eliminate errors through process standardization and automation.

This White Paper by Aman Gupta explains six steps that can lead to successful execution of APR-PQR process automation, helping eliminate regulatory reporting errors.

About the Author:

Aman Gupta is an experienced business process consultant. He has worked in several industries including Pharma to help clients in streamlining their processes for productivity gains. He is a CPIM & CSCP (Certified in Production and Inventory Management & Certified Supply Chain Professional), having good command on process areas like demand management, regulatory compliance, online campaign management, supply chain and software package implementation. He can be reached at [email protected].

Several surveys conducted in 2009 showed that around 61% of American adults get their health information from the internet. Around 79% of patients also believe that they learn more about medicines from the manufacturers’ social media channels.

This uptick in numbers of people who use the internet for more information on regulated products has forced the FDA to address the issue of using social media and the internet to disseminate information on regulated products.
 

The FDA has published a guidance document detailing which studies should be included in the clinical studies section of prescription drug labeling, how individual studies should be described, and what data should be presented. The guidance aims at making the clinical section labeling more useful, helping promote consistency in content and format across various drug product classes and indications.

This article describes the best practices to comply with the recommendations in this guidance.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions. This article gives the best practices for complying with the adverse reactions section of labeling for human prescription drug and biological products.

The Food and Drug Administration (FDA) receives spontaneous adverse event reports from health care professionals and consumers. A manufacturer, upon receiving an adverse event report from a patient or health care professional, has to send a report to FDA.  The U.S. Department of Health and Human Services (HHS) Food and Drug Administration Center for Biologics Evaluation and Research (CBER) has mandated reporting of adverse events and has issued guidance towards this end.

This article describes the best practices to be followed in the reporting of adverse events.

Off-label use is the practice of prescribing drugs for an unapproved condition or in an unapproved age group, unapproved dose or unapproved form of administration.  Unlike the drugs approved by the Food and Drug Administration (FDA), off-label drugs do not undergo mandatory clinical trials to determine the dosages, efficacy, or side effects.

This article discusses the best practices to be followed in the off-label marketing of drugs.

Abbreviated New Drug Application (ANDA) is an application for approval of a generic drug. This application is submitted to the FDA Center for Drug Evaluation and Research (CDER) for review and approval. Using bioequivalence for generic drug approval was established by the Waxman-Hatch Act. 

This article describes the requirements for bioequivalence data submission for ANDA to the FDA.

In this article, Yara Almouti, an expert on pharmaceutical cGMP, will further detail the requirements of ISO 14644-1. The article discusses the statistical treatment of the particle concentration test results data, and gives an example of the application of all the theories and equations mentioned in the previous article in this series.

This compliance guidance is intended to assist companies that develop, manufacture, market, and sell pharmaceutical drugs or biological products (pharmaceutical manufacturers) in developing and implementing internal controls and procedures that promote adherence to applicable statutes, regulations, and requirements of the federal health care programs¹ and in evaluating and, as necessary, refining existing compliance programs.

This guidance provides the OIG’s views on the fundamental elements of pharmaceutical manufacturer compliance programs and principles that each pharmaceutical manufacturer should consider when creating and implementing an effective compliance program