Good Manufacturing Practices-Herbal Industry

Teacher

Dr G V Ramana

Category

Core Courses

Course Attendees

Still no participant

Course Reviews

Still no reviews

Good Manufacturing Practices-Herbal Industry

Code(Credit) : CUTM1178(2-0-1)

Code(Credit) : CUTM1429(3-1-0)

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.

Learning 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, Airlock, Clean area, Critical operation, cross-contamination, Calibration, Pipe work, light fittings, ventilation points, other services like Sanitation and hygiene.
Module II
Qualification - Contract production and analysis, Self-inspection, Personnel, Training, Personal hygiene, Premises, Equipment, Materials, Documentation, Batch number (or lot number), Batch records, In-process control, Intermediate product, Master formula, SOP, OCP, HIRA, Good practices in production, Packaging, Packaging material, Qualification, Good practices in quality control.
Module III
Validation – Introduction, Basic concepts, types and stages of validation, validation master plan (VMP), equipment validation. Concept of URS, DQ, IQ, OQ & PQ and process-types. Prospective, concurrent and retrospective validation & revalidation.
Module IV
Quality assurance in Herbal Drug Industry concept of TQM, GLP, ISO-9000, 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.
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

Session 1

I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Session 2

I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Case Studies

Case Studies

Recent Comments

    Our Main Teachers

    Dr G V Ramana

    HOD Phytopharmaceuticals
    VIEW PROFILE

    Medicinal and Aromatic Plants, Pharmacognosy, Phytochemistry and Extraction technologies