Course Objectives

To provide knowledge on GMP ‘s and elucidating their impact on production quality. To introduce the concept of quality standards in terms of ISO-9000 and quality audit. To enlighten the issues in relevance to Hazard analysis and critical points.

Course Outcomes

Students studying this course will understand the necessity of GMP’s. They will know how to maintain the quality through the audits and allow them to maintain homogenous quality throughout the production line.

Course Syllabus

Theory
Module I
Guidelines for the manufacture of herbal medicines - Quality assurance in the manufacture of herbal medicines, Good manufacturing practice for herbal medicines.

Module II

Airlock, Clean area, Critical operation, cross-contamination, Calibration, Pipe work, light fittings, ventilation points, other services like Sanitation and hygiene.
Module III
Qualification - Contract production and analysis, Self-inspection, Personnel, Training, Personal hygiene, Premises, Equipment, Materials, Documentation, Batch number (or lot number), Batch records.

Module IV

In-process control, Intermediate product, Master formula, SOP, OCP, HIRA, Good practices in production, Packaging, Packaging material, Qualification, Good practices in quality control.
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Suggested Readings
Good Manufacturing Practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 823).
Validation of analytical procedures used in the examination of pharmaceutical materials. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report.
Geneva, World Health Organization, 1992, Annex 5 (WHO Technical Report Series, No. 823). General guidelines for methodologies on research and evaluation of traditional medicine.
Geneva, World Health Organization, 2000. 6. Quality control methods for medicinal plant materials. Geneva, World Health Organization, 1998.

Session Plan

Season 1-3

Guidelines for the manufacture of herbal medicines - Quality assurance in the manufacture of herbal medicines, Good manufacturing practice for herbal medicines. Good manufacturing practice (GMP).ppt, WHO GMP Guidelines Annex 2.pdf

Season 4-6

1000 words capstone project with examples from case studies on: Quality Assurance of Herbal Formulations. WHO Guidelines

Season 7-9

Airlock, Clean area, Critical operation, cross-contamination, Calibration, Pipe work, light fittings, ventilation points, other services like Sanitation and hygiene. PPT, WHO ANNEX 3

Season 10-11

1000 words capstone project with examples from case studies on: Importance of sanitation and hygiene in herbal drug production plant. WHO ANNEX 3

Season 12-13

1000 words capstone project with examples from case studies on: Design aspects of clean room. WHO ANNEX 3

Season 14-18
Qualification - Contract production and analysis, Self-inspection, Personnel, Training, Personal hygiene, Premises, Equipment, Materials, Documentation, Batch number (or lot number), Batch records. Contract manufacturing.ppt, self inspection.ppt,  Personnel.ppt, Premises and Equipment.ppt, Materials.ppt,  Documentation

Season 19-20

1000 words capstone project with examples from case studies on: Quality control methods for raw herbal materials. Mehtods.pdf

Season 21-24

In-process control, Intermediate product, Master formula, SOP, OCP, HIRA, Good practices in production, Packaging, Packaging material, Qualification, Good practices in quality control. Process control.ppt,  Master formula, SOP. PDF,  Hazzard Identification and management WHO guidelines.pdf,  Packaging

 Season 25-26

1000 words capstone project with examples from case studies on: Self-Inspection and Quality Audit Regulations in India.

Season 27-29

Validation – Introduction, Basic concepts, types and stages of validation, Validation master plan (VMP), equipment validation. Validation_WHO Guidelines.pdf, Pharmaceutical validation.ppt

Season 30-31

1000 words capstone project with examples from case studies on: In-process control and its role in product quality.

Season 32-34

Concept of URS, DQ, IQ, OQ & PQ and process-types. Prospective, concurrent and retrospective validation & revalidation. Concept of URS,DQ,IQ,OQ,PQ.ppt, PROCESS VALIDATION.ppt, WHO Guidelines on Validation

Season 36-38
Quality assurance in Herbal Drug Industry concept of TQM, GLP, ISO-9000. Quality assurance of herbal products.ppt, Concepts.ppt

Season 39-40

1000 words capstone project with examples from case studies on: In-process control and its role in product quality.

Season 41-42

Quality audit, Suppliers’ audits and approval, Auditing of Storage area, Weighing areas, Production area, Intermediate and bulk products and finished products, HACCP in traditional system of medicine.
Quality assurance audits.ppt, HACCP.ppt.

Season 43-44

1000 words capstone project with examples from case studies on: A) Validation and its role in cGMP. B) Write a validation master plan for an herbal production facility.