PY8005 - VALIDATION IN PHARMACEUTICAL INDUSTRIES (Syllabus) 2017-regulation Anna University

PY8005 - VALIDATION IN PHARMACEUTICAL INDUSTRIES (Syllabus) 2017-regulation Anna University

PY8005	VALIDATION IN PHARMACEUTICAL INDUSTRIES	LPTC

3003

OBJECTIVES:

• To provide the information on GMP/GLP regulation involved in the manufacturing Of API and biological products.
• To provide the importance of impurity profile and stability testing of drugs.

UNIT I	DRUGS AND COSMETICS ACT AND GMP FOR API	9

Drugs and cosmetics act-1948–Organization and personnel –Buildings and facilities –Equipment – Documentation a n d records–Material management– Production a n d in process control– Packaging and labelling–Storage Distribution.

UNIT II	IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS	9

Definition of impurities–Validation and impurity issue related to manufacturing –Processing of drug substances –Enantiomers as impurities –Polymorphs as unwanted components.

UNIT III	CLEANING PROCEDURE IN API MANUFACTURING FACILITIES	9

Regulatory requirements–Multiple vs dedicated equipment– Unique nature of API–Multiple level approach to cleaning–Nature of contaminants–Selection of a worst case–Cleaning techniques – Sampling – Analytical methods – Limits and acceptance criteria, documentation.

UNIT IV	STABILITY TESTING	9

Reasons for stability testing–Modes of degradation –Shelflives and expiration dates– Possible strategies to improve shelflives–Stability testing of new drug substances andproducts(Q1A)– Photostability testing of new substances and products(Q1B)–Validation on analytical procedures(Q2A).

UNIT V	PROCESS VALIDATION	9

Process validation as a quality assurance tool-General QA tools, purpose of process validation, Qualification activities, Process validation activities. Prospective process validation-Organization, documentation, product development, development of manufacturing capability, full scale production development, defining experimental programs, experimental design and analysis.

TOTAL : 45 PERIODS

OUTCOMES: The students will be able to

• Understand regulatory practices and administrative functions adopted in the Pharmaceutical organizations.
• Understand the importance of impurity and the procedure for determination of expiry date.
• Understand the role of cleanliness in manufacturing high purity products and reducing adverse products

TEXT BOOKS:

1. R.A. Nash, A.H. Wachter, “Pharmaceutical Process Validation”, 3rd ed., CRC Press, Taylor & Francis Group, 2003.
2. Y.Anjaneyulu,R. Maraya, “Quality Assurance and Quality Management in PharmaceuticalIndustry”,PharmaBookSyndicate,2005.
3. J. P. Agalloco,F.J. Carleton, “Validation of Pharmaceutical Processes”, 3rd ed., Informa Healthcare, NY, USA, 2007.

REFERENCES:

1. Willig,S.H., “Good Manufacturing Practice for Pharmaceuticals”, 5th Edition,MarcelDekker,2005.
2. A.A. Signore, T. Jacobs, “Good Design Practices for GMP Pharmaceutical Facilities” 1st ed., CBS Publishers & Distributors Pvt. Ltd., 2009.
3. S.C. Chow, “Statistical Design and Analysis of Stability Studies” Chapman and Hall/CRC, 2007.