Sage-Tips

What is the biggest issue facing Indian pharma manufacturers?

Some Challenges for the Indian Pharmaceutical Industry

• A lack of a stable pricing and policy environment-The challenge created by unexpected and frequent domestic pricing policy changes in India.
• Lack of capabilities in the innovation space-India is rich in its manpower and talent.

Does FDA audit pharmaceutical companies?

Every Pharmaceutical company is bound by FDA regulations and can expect an audit sooner or later. These audits ensure process compliance relevant to Standard Operating Procedures (SOPs), good manufacturing practices (GMPs), and other regulatory criteria.

Does FDA inspect in other countries?

FDA’s Laurie Graham, director of the division of internal policies and programs at CDER’s Office of Pharmaceutical Quality told webinar attendees that as of March 2021, the agency conducted a total of 777 prioritized domestic inspections since resuming inspections in July 2020, and from March 2020 through March 2021.

How do I audit a pharmaceutical company?

How to Do an External Audit for a Pharmaceutical Company

1. Pre-Audit Information. For planning purposes, establish why the audit is required to determine the type, scope and objectives of the audit.
2. Preparation.
3. Performing the Audit.
4. Reporting and Follow Up.

What are the challenges facing pharmaceutical industry?

Six major risks facing pharmaceutical manufacturers in 2021

• Reduced demand for prescription medicine.
• Growing competition from generic pharmaceuticals.
• Pharmaceutical fraud.
• Rising consumer expectations and difficulties managing brand health.
• Data breaches and other cybersecurity threats.
• Supply chain disruptions.

Does the FDA inspect hospitals?

Generally, the FDA only inspects facilities that register with the agency as 503B compounders. These can produce large batches of drug with or without direct prescriptions to be sold to health care facilities.

What is an FDA audit?

The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act. This typically involves an investigator visiting a firm’s location.

How do you handle an FDA inspection?

Here are six ways to make sure you are:

1. Make FDA Inspection Procedures Clear & Concise.
2. Make Key Documents & Records Easily Accessible in an Inspection-Ready Binder.
3. Label Items for Fast Retrieval.
4. Compile Product Complaints & CAPAs Since Your Last Inspection.
5. Report All Corrections/Recalls & Keep Documentation Current.

What is pharmaceutical audit?

Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose.

Why auditing is important in pharmaceutical industry?

Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products.

Did FDA action by FDA affect exports from India?

Dr. Reddy’s Laboratories’ Chairman Satish Reddy has asserted that recent regulatory action by the FDA on leading Indian firms has affected exports from the country. Reddy said that a dialogue between the Indian government and the US regulator was essential in resolving the issue.

How are USFDA inspectors auditing the Injectables at the plant?

USFDA inspectors in two teams are auditing both the injectables as well as oral solids units at the plant, with one team focusing on manufacturing processes and the other closely auditing quality control and assurance departments.

Which companies in India faced USFDA heat in 2015?

Sun Pharmaceutical, Dr. Reddy’s Laboratories, Cadila Healthcare and IPCA Laboratories were major companies that faced the USFDA heat in 2015. Dr. Reddy’s Laboratories’ Chairman Satish Reddy has asserted that recent regulatory action by the FDA on leading Indian firms has affected exports from the country.

Why are large drug companies facing FDA warning letters and notices?

Large drug companies like Wockhardt, Sun Pharma, Lupin and Ipca, which are currently facing problems because of FDA warning letters and notices, are trying to address the problem. The companies have come together to form a quality forum and are consulting global experts, including both MHRA/EDQM and US FDA, to tackle the issue.