The pharmaceutical industry is crucial for healthcare, focusing on the manufacturing and marketing of drugs, biological products, and medical devices, alongside research for new product development. Key quality management principles include ISO standards, Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP), which ensure product safety and efficacy at all stages. Regulatory bodies like the National Medicines Regulatory Authority (NMRA) oversee the quality and safety standards for medicinal products in various countries.

1. PHARMACEUTICALS INDUSTRY
MADE BY- ANIRUDH
ARPIT
JAYVARDHAN
RAHUL
AMAN

2. INTRODUCTION
 Pharmaceutical industry is a very vital segment of the
 our health care system, which deals with manufacturing
 and marketing of pharmaceuticals and biological
 products and medicinal devices, used for the diagnosis
 and treatment of diseases as well as conducts research
 for development of new products for human welfare
 TQM involves
 building quality in a pharmaceutical product as it
 involve complete records such as standard operating
 procedures for every step, validation records, master
 formula records and batch production records etc.

3. ISO9001
 ISO-9001:2015 The International Organization for
Standardization.
 As per ISO, it is defined as “Degree to which a set of inherent
characteristics fulfills requirements”.
 Developed with the participation of pharmaceutical sector
experts, ISO 15378:2006 incorporates in a single document the
quality management requirements of ISO 9001:2000 together
with the Principles of Good Manufacturing Practice (GMP) for
the design, manufacturing and supply of primary packaging
materials for medicinal products.

4. WHAT IS GMP
 Good Manufacturing Practices (GMP) relate to quality control
and quality assurance enabling companies in the
pharmaceutical sector to minimize or eliminate instances of
contamination, mix-ups, and errors. This in turn, protects the
customer from purchasing a product which is ineffective or
even dangerous.

5. GDP
 Logistics Good Distribution Practices (GDP) Certification
for Pharmaceutical Industry. Maintaining product safety and
quality during distribution is of utmost importance in
the pharmaceutical industry.Good Distribution Practices (GDP)
is a quality system for warehouse and distribution centers
dedicated for medicines.

6. CPP
 Certificate of Pharmaceutical Product. The certificate of
pharmaceutical product (abbreviated: CPP) is
a certificate issued in the format recommended by the World
Health Organization (WHO), which establishes the status of
the pharmaceutical product and of the applicant for
this certificate in the exporting country.
 No, it is only countries and regional organizations such as the
European Medicines Agency (EMA) that are party to the
Scheme who can issue a CPP.

7. FPP
 Finished Pharmaceutical Product
 A medicinal product which has undergone all stages of
production, including packaging in its final container.
API
 The Active Pharmaceutical Ingredient (API) is the part of any
drug that produces its effects. Some drugs, such as
combination therapies, have multiple active ingredients to
treat different symptoms or act in different ways.

8. BPS
 The Board of Pharmacy Specialties is a division of the American Pharmacists
Association that grants recognition to appropriate pharmacy practice
specialties and establishes standards for certification of pharmacists in these
specialties

9. SLSPP
 Statement of Licensing Status of Pharmaceutical Products
NMRA
 The National Medicines Regulatory Authority (NMRA), plays a
leading role in protecting and improving public health by
ensuring medicinal products available in the country meet
applicable standards of safety, quality and efficacy. The
Authority regulates medicines, medical devices, borderline
products, clinical trials and cosmetics. The National Medicines
Quality Assurance Laboratory (NMQAL), charged with
ensuring quality of medicinal products, also functions under
the purview of the NMRA.