Compliance Resources to Help you Stay Current

When the internet was not as ubiquitous as it is today, Life Sciences Companies maintained documents manually. Submitting truckloads of paper records to the FDA was a norm when the U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 back in 1997.

With the evolution of the internet, more companies joined the inevitable movement toward the use of electronic systems. This article is a ready reckoner for Companies that are looking to buy COTS (Commercial Off-The-Shelf) software to automate their document and business process management. It guides buyers through the process and helps Companies maintain constant inspection readiness.

Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices

Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of cGMP Controlled Raw Materials is critical to Life sciences personnel to gain drug approvals.

Onboarding Training for New Hires in GMP Environment: Are You Complying?

Onboarding training for the new hires in the GMP environment is a difficult task. Compliance requirements, quality concerns and work culture are all important considerations. Are contractors treated the same as long-term employees? Where does GMP training end and HR training begin? When can employees begin working? And all other barrage of questions need to be addressed.

ICH Q3D Elemental Impurity Guidelines: Are You Prepared for January 2018?

While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to go into effect in 2018, implementation requires extensive prior work. The new elemental impurities limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms.

FDA Import Program: How to Comply with Regulatory Requirements?

U.S. Customs and Border Protection (CBP) and FDA work concurrently during the import entry process and rely on each other’s import requirements to determine the admissibility of a product. The typical import process begins with the CBP service, which collects tariffs that have been placed on imported goods. There are some basic steps that should be considered to start the import process with CBP. Once the import process starts, FDA will be involved as another government agency as it has overlapping jurisdiction over the product.

Drug Master Files: All You Need to Know

Drug Master File (DMF) is a package of confidential, proprietary assets, detailing the formulae, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Though there are no regulatory requirements to file a DMF, the benefit of its use is overwhelming. A DMF filing help firms maintain confidentiality of proprietary information and yet ensure compliance with regulatory requirements for disclosure of product details.

FDA Releases Long Awaited Biosimilar Interchangeability Draft Guidance

The US FDA has finally issued its much awaited draft regulation on biological product interchangeability. The regulatory guidance has been expected since 2010, when Patient Protection and Affordable Care Act was signed into law, that amended the Public Health Service Act to create an abbreviated license pathway for biological products that are proved to be biosimilar or interchangeable with an FDA-licensed biological product.

FDA Issues Draft Regulatory Documents on Nutrition Facts Label and Serving Size

The U.S. FDA has recently released two draft guidance documents on Nutrition Facts Labeling and Serving Sizes to aid industry comply with the final rules issued by Agency in May 2016. The Final Nutrition Fact Label rule released in May 2016 marked the first comprehensive revamp of the label in 20 years.

Aimed at spurring medical innovation, expanding mental health treatment, speeding up access to new drugs, and combatting opioid abuse, the bill, termed 21st Century Cures Act, promises plenty.

The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were falsely connected to a healthcare’s facility oxygen supply system.

FDA in the Federal Register said, “The final rule is intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container.”

The US FDA recently held a 2-day public hearing to seek input for more flexible regulations on off-label promotion for drugs and devices. Pharmaceutical, medical device, and insurance industries, health and safety advocates, as well as physicians and patients packed a room for two full days at the FDA’s campus to debate on these rules and regulations.

Dr. Robert Califf, the FDA commissioner, said that ultimately, the analysis of the regulations is to ensure that the system "best protects and promotes the public health and the well-being of patients."

Pharmaceutical companies stated that current marketing regulations are too restrictive.

Patients argued that relaxing these regulations would be a "public health disaster."

The US FDA has issued final guidance intended to assist FDA staff and those in the healthcare industry with submitting investigational device exemption (IDE) applications to conduct clinical trials for neurological medical devices.

The guidance applies to medical devices designed to target the cause or progression of neurological diseases, such as Alzheimer’s disease, Parkinson’s disease, or primary dystonia. The final guidance offers general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments.

While regulators point out that the key to making profits in the pharmaceutical industry is innovation and breakthrough, they are left investigating an alternative that several industry giants seem to explore - price collusion.

Drug pricing practices in the pharma industry have drawn a lot of flak from various quarters and now lawmakers are turning their attention to this emerging trend. Price hikes at Valeant Pharmaceuticals, Mylan, and others are under close scrutiny, while federal antitrust regulators probe whether Merck & Co Inc, Sanofi SA, Novo Nordisk A/S, and Eli Lilly and Co colluded to fix prices for insulin and other diabetes drugs.

Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. The FDA guidance also addresses the United States Pharmacopeial Convention’s (USP’s) requirements which go into effect on January 1, 2018.

Pharmaceutical Quality by Design (QbD): Understanding its Principles

Quality is a prime factor of importance in this era of competition. More and more pharmaceutical companies today are embracing the principles of Quality by Design (QbD) for development and manufacturing. The principles of quality have been defined by three the ICH guidelines: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality system.

QbD is a recent concept which has been included as an annex to ICH Q8 Guidance. QbD enables better process understanding, and a more scientific approach to development rather than mere testing of the final product.

The US Food and Drug Administration (FDA) published a final guidance on October 14, 2016 describing how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to prior approval supplements (PAS) submissions. The guidance also explains the amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

What's Safe in Your Medicine Cabinet: Dietary Supplements in the U.S.

From regulating hormone levels to supplementing nutritional deficiencies in children, dietary supplements have a broad spectrum of needs to cater to. Popping a vitamin pill or biting down on an energy bar is not as simple as it once was though. The plethora of products available to supplement your diet are so staggering that regulating what reaches the consumer has been a challenge of equal proportions.

When the FDA first decided it was time to regulate dietary supplements in the early 90s, the agency drew a lot more flak than it could have anticipated. The flak came from trade associations of dietary supplement manufacturers and consumers. The industry has since witnessed a booming growth, resulting today in the need for FDA to step in with guidance and oversight for its labeling, marketing, and post-marketing as well.

Anticipating and Closing Out FDA Warning Letters

How can an FDA regulated company know that a Warning Letter is definitely on its way? What are the signs that can help firms anticipate a letter from the regulator? What is the groundwork that can be done before the receipt of the Warning Letter so that when it indeed arrives, the company is ready for it and implements the close-out process quickly and effectively? The answers to these questions are vital in ensuring the FDA Warning Letter response and close-out program is handled in a thorough manner that leaves nothing to chance.

The FDA, which regulates dietary supplement products and their ingredients, recently warned manufacturers of dietary supplements containing DMAA (1, 3-dimethylamylamine) for not providing evidence regarding safety of their products. The Agency thus deemed the products as 'adulterated' (as DMAA is known to cause serious side-effects) and sent warning letters to 10 manufacturing firms for failing to demonstrate the safety of their products.

On May 10 2012, the FDA released new draft guidance on "Paediatric Information for X-ray Imaging Device Premarket Notifications". This new guidance provides health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on paediatric patients. This guidance applies only to complete x-ray imaging devices that could be used on paediatric patients.