Definition Of Pharmaceutical Product

The term of “pharmaceutical products” is defined in the section 2 of PPO. Application for registration of pharmaceutical products is made to the PPB, a statutory body to determine whether or not that product is a pharmaceutical product and require to be registered. Compromise on the quality of pharmaceutical products would mean a compromise on the overall health of the patients and other clients. It is a well-known fact that good quality products are much more efficient and effective. Production of an effective drug is the ultimate goal of any well-meaning pharmaceutical company. Pharmaceutical definition: Pharmaceutical means connected with the industrial production of medicine. Meaning, pronunciation, translations and examples.

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On October 15, 2020, FDA announced two new pilot programs to gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system.

  • The Quality Management Maturity for Finished Dosage Forms Pilot Program (QMM FDF Pilot Program) is for domestic drug product manufacturers of prescription and over-the-counter (OTC) drug products.
  • The Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program (QMM API Pilot Program) is for foreign manufacturers of active pharmaceutical ingredients (APIs), including drug substance intermediates used to produce APIs, used in FDA-regulated prescription and OTC drug products.
  • For more information, please view FDA’s webinar on CDER’s Quality Management Maturity Program here.

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. CDER established the Office of Pharmaceutical Quality (OPQ) to ensure a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all human drug product areas – new drugs and biologics, generics, and biosimilars—and also over-the-counter drugs and compounded drug products. This white paper provides additional background regarding OPQ and the FDA’s oversight of pharmaceutical quality.

Patients and consumers can learn more about quality and how Current Good Manufacturing Practices (CGMPs) impact them.

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The resources below offer information on pharmaceutical quality topics for manufacturers and applicants.

As part of an application to make a drug applicants are expected to show that they can consistently produce a quality product. The following resources are helpful in achieving this goal. They provide information relevant to various application types and may also be helpful for other types of products such as OTC monograph products:Pharmaceutical
  • Quality Related Guidances go to Search for FDA Guidance Documents and filter by
    • FDA Organization - Center for Drug Evaluation and Research and
    • Topic
      • ICH-Quality
      • Chemistry, Manufacturing, and Controls (CMC)
      • Microbiology
      • Current Good Manufacturing Practice (CGMP)

Definition Of Thermolabile Pharmaceutical Products

The following resources provide additional details for specific types of applications:

  • Generic Drugs: Information for Industry
In addition to our CGMP regulations, the following resources expand on FDA’s post-application expectations for manufacturers of drug substances and drug products.
  • CGMP related guidance (i.e. operating a drug manufacturing facility to acceptable standards on an ongoing basis) go to Search for FDA Guidance Documents and filter by
    • FDA Organization - Center for Drug Evaluation and Research and
    • Topic
      • ICH-Quality
      • Current Good Manufacturing Practice (CGMP)
  • Report a Product Quality Issue: Identify quality defects in distributed drug products that may present a potential safety threat

FDA is also engaged in efforts to foster innovations in manufacturing processes and technology and to foster a quality culture. This includes re-aligning FDA programs and surveillance activities to ensure efficient and effective regulatory oversight.

Product
  • Through an FDA funded research contract, Dun & Bradstreet (D&B) is partnering with the University of St.Gallen in Switzerland to conduct research to benchmark pharmaceutical quality management systems. The Quality Benchmarking Study (QBS) will produce a globally representative baseline data set that characterizes quality management among human drug manufacturers.
  • Through our Emerging Technology Program, FDA meets with companies developing technologies that may offer significant improvements to pharmaceutical quality and provides recommendations to help support anticipated applications. The Emerging Technology Team has considered continuous manufacturing, 3D printing, and a variety of other technologies.
    • FDA also continues to support other advanced manufacturing technologies, such as Process Analytical Technology.
  • International Collaborations: FDA also engages foreign regulatory counterparts to coordinate on ways to advance product quality. For example, we work with the International Council on Harmonisation to develop harmonized quality standards and facilitate implementation by industry. FDA is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which is an international organization dedicated to harmonizing inspection practices and related policies. FDA has also engaged in initiatives such as the Mutual Recognition Agreement to utilize inspectional observations from capable regulatory authorities, reduce duplicative efforts, and focus resources and inspections on facilities that pose the greatest risk.
  • In June 2017, CDER and ORA entered into a Concept of Operations to integrate facility evaluations and inspections for human drugs. See our Q&A page for additional details about how this collaboration will improve consistency, efficiency and transparency for facility evaluations and inspections.
  • Quality metrics are used to monitor quality control systems and drive continuous improvement efforts. FDA’s quality metrics webpage provides background on the FDA’s efforts to initiate a voluntary reporting program so that key metrics can be provided to the FDA.
  • Science and research pertaining to drug product quality remains the foundation that underlies sound regulatory decisions. OPQ established research Centers of Excellence to provide platforms for centralized, focused research collaboration and communication.

Contact for Further Information:


Patient discussion about medication

Q. is it ok to use drugs for medical reasons? and who is to decide when is necessary to use drugs when needed?

A. Today the most used 'medical' drugs are narcotics- for pain relief, for patients who suffer extreme pain. All sorts of Codaine and Morphine types are used and on a very wide basis, and they are specially perscribed for ones who need them.

Definition Of Pharmaceutical Products

Q. How about Psychiatric Drugs for bipolar? One of my friend is suffering from bipolar. Will Psychiatric medications help him to come out of this affect?

A. from what i read- there are certain medication that can help. if the first one doesn't - there is a second and third line of medication. from a personal experience (not mine, a friend of the family) it can even save your friend's life.

Definition Stability Of Pharmaceutical Products

Q. What medications are forbidden to take with alcohol? And why is that?

A. I think this web page will give you something to think about:
http://pubs.niaaa.nih.gov/publications/aa27.htm
apparently there are more drugs you shouldn’t mix with alcohol then I could think of…
More discussions about medication

List Of Pharmaceutical Products

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