Pharma Blog
Osteoarthritis Management Guidelines
Osteoarthritis (OA) is the most common form of arthritis, and is a leading cause of disability among older adults. The knees, hips, and hands are the most commonly affected by osteoarthritis. Osteoarthritis (OA) is characterized by pathology involving the whole joint, including cartilage degradation, bone remodeling, osteophyte formation, and synovial ... Read More
Validation and Qualification In Pharmaceutical Manufacturing
What is Validation? As per EU GMP – It is “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to expected results. What is Qualification? Comparison between Qualification and Validation Why Validation? What to Qualify/Validate? ... Read More
COPD Management Guidelines
Chronic obstructive pulmonary disease (COPD) is a group of chronic lung diseases that block air flow in lungs, such as chronic bronchitis. Symptoms of COPD Diagnosis of COPD Patients who are older than 40 years of age and who are current or ex-smokers should undertake spirometry if they answer yes ... Read More
GMP in Pharmaceutical Industry
GMP stands for Good Manufacturing Practices. It is a set of guidelines and regulations to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use. This includes guidelines for the design, monitoring, and control of manufacturing processes, as well as quality control ... Read More
Patents and Exclusivity in Pharmaceutical Industry
Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website? Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top selling prescription brand-name drugs, sponsors of ... Read More
Diabetes Management Guidelines
Diabetes mellitus is a chronic metabolic disorder characterized by high blood sugar (hyperglycemia) in human body. This results from lack of insulin in the body or failure of body cells to respond to circulating insulin. Persistent hyperglycemia results in progressive multiple organ damage giving rise to both acute and chronic ... Read More
Walking Through the 21 CFR Part 11
If you are connected to the life sciences industry in one way or another, you have undoubtedly heard of the United States Food and Drug Administration’s (FDA’s) 21 Part 11 Regulation. We begin by decoding 21 CFR Part 11 itself: The CFR is organized like this: Title > Chapter > ... Read More
Vendor Audit in Pharmaceutical Industry
Vendor audit is an evaluation of a vendor manufacturing process, practices, documentations and quality compliance by offline (physical) or online (desktop). Conducting a vendor audit in the pharmaceutical industry is an essential process to ensure that suppliers and vendors meet the required standards and regulations. Vendor Audit Process Define Audit ... Read More
Safety Measures for Cell Culture Laboratory
A cell culture laboratory poses risks associated with handling and manipulating cells and tissues as well as toxic, corrosive or mutagenic solvents and reagents. Therefore, adherence to standard microbiological practices and techniques is of paramount importance to mitigate risks and ensure safety at all times. There are four ascending levels ... Read More
Obesity Management Guidelines
The American Medical Association (AMA) designated obesity as a chronic disease and the World Health Organization (WHO) defines obesity as a body mass index (BMI) of ≥ 30 kg/m2. It is associated with numerous health factors – diabetes, hypertension, arthritis, sleep disorder, high cholesterol, and other chronic health conditions. The ... Read More
APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
The EMA and other Health authorities have published requirements (EMA/189634/2019) and Health Canada Letter for the API industry and the MAH for drug products to expand the scope of potential sources of nitrosamines beyond that of ICH M7. This requirement is based on the fact that, as the Industry and ... Read More