Phyto Pharmacy

Current Concepts and GMP Norms

Food

Drug Poison

Priyogah shamyet vyadhim yah anyamanyamudiret; Naso vishudhah shudhastu shamyedwau na kopyet.
(Vagbhatta A. H. Su. 13:16)

The therapy which pacifies diseases and gives rise to other diseases is not pure therapy. The pure is one which pacifies without erupting other problems.

Ayurvedic Medicines Herbal Medicines Holistic Medicines

(Health Restoration)

Modern Medicines
(Disease Management)

Green Pharmacy

Red Pharmacy

Green Facts
Current Global Market: US$150 billion (As per WHO)

Projection for 2050: US$5000 billion (As per WHO)

Chinese Foreign Exchange: Rs 22,000 Crores Indian Share: Rs 500 Crores Chinese Plant Resource: 30% Indian Plant Resource: 30% Indian System: Time tested, trusted and well

structured Chinese System: Not so well trusted and structured Some Recent Greens: Ranbaxy, HLL, Colgate

Export of Herbal Products From India

Manufacturing Quality Control Quality Assurance

Good Practices
Good Manufacturing Practices
Good Laboratory Practices Good Agricultural Practices
(WHO/ Feb 2004)

The Regulation
Drugs and Cosmetics Act 1940 (Section 33-N) Drugs and Cosmetics Rules 1945
Drugs and Cosmetics (Amendment) Rules 1999 Schedule T

Schedule T
Raw materials used in manufacturing of drugs are

authentic, of prescribed quality and free from contamination. The manufacturing process is as has been prescribed and maintains standards of purity. Adequate quality control measures are taken and The manufactured drug which is released for sale is of acceptable quality.
To achieve the objectives listed above each licensee shall evolve methodology and procedures for manufacture of drugs which should be documented as a manual and kept for reference and inspection.
(Vaidyas, Sidhdhas and Hakeems dispensing medicines to their own patients are exempted)

GMP Norms
Factory Premises
The manufacturing plant should have adequate space for:

1. 2.

3.
4. 5. 6.

Receiving and storing raw materials Manufacturing process areas Quality control unit including in-house testing facilities Finished goods store Office Rejected goods store

(Minimum for any one system 1200 sq feet covered area with separate cabins for each activity. Additional 400 sq feet for each additional system)

General Requirements
Location and Surroundings Away from open sewage, drain, public lavatory and factories producing obnoxious odor, fumes, dust or smoke. Buildings Hygienic and free from cobwebs, insects and rodents Designed to prevent Cross-contamination

Water Supply Potable & Other

Disposal of Waste Predisposal Treatment

Health, Clothing, Sanitation and Hygiene

of Workers
Workers to be free from contagious diseases Uniform Suitable for climate and nature of work including coverings for hands, feet and head wherever required Facilities for personal cleanliness Clean towels, soap, scrubbing brushes, lavatories, change rooms & place for keeping personal belongings. Medical Services First aid Medical Examination: At the time of employment and at least once in a year

Raw Materials
Separate and adequate facilities for Raw materials of metallic origin Raw materials of mineral origin Raw materials from animal source Fresh herbs Dry herbs or plant parts Excipients etc. Volatile oils, perfumes and flavors Plant extracts, exudates and resins
Labeling: UNDER TEST or APPROVED or

REJECTED

Packaging Material
Storage
Testing Cleaning Controls on printed materials to avoid

wrong labeling

Working Space
Adequate for orderly placement of

equipments and materials To facilitate easy and safe working To minimize/ eliminate risk of mix-ups and cross contamination

Equipments
Nature, number and sizes
Installation and maintenance record Cleaning SOPs and Records

Operation SOPs

e.g.

Anjana/ Pisti: Kharel/ ball mill, sieves/ shifter Churna: Grinder/ disintegrator/ pulverizer, powder mixer, sieves/ shifter Ark: Maceration tank, distillation plant, liquid filling tank with filter/ filter press, visual inspection box

Finished Goods Store

Quarantine Area
Approved Finished Goods Stock Area

Quality Control
Lab

Personnel: To be headed by an independent

person. Duties:

To prepare specifications and testing methods for raw materials and finished products. To sample, test, approve or reject RMs, PMs, semi-finished product and finished products. To supervise and monitor the adequacy of storage conditions. Maintenance of the records of each process where testing of finished product is not possible.

Records
Batch Manufacturing Records (BMR)
Distribution Records
(to facilitate recall)

Record of Market Complaints and

Adverse Drug Reactions

B. Pharm./ M. Pharm.
Quality Control, Legal Aspects & Documentation
1. Quality Perspectives of Ayurvedic-herbal Products: Status of quality standards for Ayurvedic-herbal products. Databases for identification and authentication of materials. Chemoprofiling & bio-profiling of Ayurvedic-herbal products. Protocols for establishing purity of materials, identification of adulterants, substitutes, pathogenic bacteria & fungi, heavy metals and pesticide residues. Validation of traditional claims through scientific studies and clinical trials. 2. Quality Control: Control of manufacturing processes, statistical quality control, control charts, sampling plans, automated process controls, dosage form controls, Testing programs methods. Product identification systems, adulteration & misbranding. Maintenance of records. Bioavailability & bio-equivalence. Manufacturers reliability. Manufacturer/drug information profile.

3. Good Manufacturing Practices: GMP in manufacturing, processing, packaging and holding of drugs. Control of Components, containers and closures. Packaging & labeling controls. Inspection for compliance with GMP. Potable water standards. Premises- design, construction, maintenance, equipments. Warehousing. 4. Pharmaceutical Process Validation: Regulatory basis, validation of sterile products & non-sterile products and processes thereof. Analytical method validation. Validation of computer assisted processes. 5. Drug Regulatory Aspects: National and international bodies for drug regulation. Federal food, drug and cosmetic acts along with recent amendments. New drug application, drug efficacy study, implementation review, OTC drug review, drug listing. Drug recalls, product liability, clinical trials. ICH guidelines. WHO & ISO certification. Patents, copyright & trade marks. 6. Documentation: Relevance and importance of documentation, statuary requirements and procedure for documentation, critical examination of documents.