Scholar

Dr.Bidhan Mahajon

Guide

Dr. Remadevi.R. MD(AYU)

Professor and H.O.D

Department of Dravyaguna Vijnanam V.P.S.V. Ayurveda College

Kottakkal 1

Good Agricultural and Cultivation

Practices(GACP)

Good Manufacturing Practices(GMP)

Good Laboratory Practices(GLP)

Good clinical practices(GCP)

WHAT IS GMP?

• WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.”

QUALITY Quality of a medicinal product is measured by it’s fitness for purpose

Quality Control And Quality Assurance

• Operational laboratory techniques and activities used to fulfill the requirement of Quality

• QC is lab based

• All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality

• QA is company based

GMP helps to boost pharmaceuticalexport opportunities

Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP

Certifying agencies• ICH www.ich.org• WHO www.who.int• USFDA www.fda.gov• EU .www.emea.europa.eu

• In India, the Schedule T of Drug and Cosmetic Act of 1940 deals with the license to be issued to the manufacturer with GMP standards

GMP HERBAL MEDICINES NORMS

• 1. Quality assurance in the manufacture of herbal medicines • 2. Good manufacturing practice for herbal medicines • 3. Sanitation and hygiene • 4. Qualification and validation • 5. Complaints • 6. Product recalls • 7. Contract production and analysis • 8. Self-inspection • 9. Personnel • 10. Training • 11. Personal hygiene • 12. Premises • 13. Equipments• 14. Materials• 15. Documentation • 16. Good practices in production .• 17. Good practices in quality control

1. QUALITY ASSURANCE IN THE MANUFACTURE OF HERBAL MEDICINES

Quality assurance”- is a wide-ranging concept covering all matters that

individually or collectively influence the quality of a product

2. GOOD MANUFACTURING PRACTICE FOR HERBAL MEDICINE

• First step- cultivation and collection of medicinal plants

• This ensures the quality, safety and efficacy of the complex products of biological origin

3. Sanitation and Hygiene

A high level of sanitation and hygiene during manufacture is necessary because herbal products are prone to contamination

4.Qualification and validation

Qualification of critical equipment process validation are particularly important in the production of herbal medicines with unknown therapeutically active constituents

5. Complaints

COMPLAINTS

PRODUCT ADVERSE REACTION QUALITY COMPLAINT

PRODUCT QUALITY COMPLAINTS

causes – faulty manufacture, product defects or

deterioration, adulteration of the herbal material

The complaints should be recorded in detail and the causes thoroughly investigated (e.g. by comparison with the reference samples kept from the same batch)

There should be written procedures to describe the action to be taken.

ADVERSE REACTION/ EVENTSReports of any adverse reaction/event should be entered in a separate register in accordance with national and international requirements

An investigation should be conducted to find out whether the adverse reaction/event is due to a quality problem and whether such reactions/events have already been reported in the literature or whether it is a new observationComplaint records should be reviewed regularly to detect any specific or recurring problems requiring special attention and possible recall of marketed products

The WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems deal with specific issues relating to adverse reactions and adverse events following treatment

with herbal medicines

6.PRODUCT RECALL

There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective.

7. CONTRACT PRODUCTION AND ANALYSIS

Contract production and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a product or work or analysis of unsatisfactory quality.

8. SELF - INSPECTION

• The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control

9. PERSONNEL The manufacturer should have an

adequate number of personnel with the necessary qualifications and practical experience.

• All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.

• All personnel should be motivated to support the establishment and maintenance of high quality standards

• Key personnel

Key personnel include the head of production, the head of quality control and the authorized person

The heads of production and quality control

should be independent of each other

10. TRAINING

The personnel should have adequate training in appropriate fields such as pharmaceutical technology, taxono micbotany,

Phytochemistry, pharmacognosy, hygiene,microbiology and related subjects

11. PERSONAL HYGENE

• Personnel must be protected from contact with toxic irritants and potentially allergenic plant materials by means of adequate protective clothing

• They should wear suitable gloves, caps, masks, work suits and shoes throughout the whole procedure from plant processing to product manufacture.

12. PREMISES STORAGE AREAS• Storage areas should be well organized and tidy. • Herbal materials, including raw herbal

materials, should be kept in a dry area protected from moisture and processed following the principle of “first in,first out” (FIFO)

PRODUCTION AREA To facilitate cleaning and to avoid cross-

contamination, adequate precautions should be taken during the sampling, weighing,

mixing and processing of medicinal plants

13. EQUIPMENT

• Processing of herbal materials may generate dust or material which is susceptible to pest-infestation or microbiological contamination and cross contamination

• Vacuum or wet-cleaning methods are preferred

• Non-wooden equipment should be used unless tradition demands wooden material

14. MATERIALS• All incoming herbal materials should be

quarantined and stored under appropriate conditions

• Only permitted substances should be used for fumigation

• Reference samples and standards

15. DOCUMENTATION

• Herbal materials• The family and botanical name of

the plant used according to the binomial system

• The vernacular name and the therapeutic use in the country or region of origin of the plant

Finished herbal products

• Tests for microbiological contamination and tests for other toxicants

• Uniformity of weight, disintegration time, hardness and friability, viscosity, consistency and dissolution should be documented

• Physical appearance such as colour, odour, form, shape, size and texture

• Identity tests, qualitative determination of relevant substances of the plants

16. GOOD PRACTICES IN PRODUCTION

• Collection/cultivation and /or harvesting of medicinal plants should follow the WHO Guideline on good agriculture and collection practices (GACP) for medicinal plants

17. GOOD PRACTICES IN QUALITY CONTROL

GENERAL• The personnel of quality control units should

have the necessary expertise in herbal medicines to enable them to carry out identification tests and recognize adulteration, the presence of fungal growth or infestations and lack of uniformity in a consignment of herbal materials

SAMPLING• Herbal materials should have an element of

heterogeneity, so sampling should be carried out with special care by personnel

TESTING• The identity and quality of herbal material,

herbal preparations and of finished herbal products should be tested as described in the Quality control methods for medicinal plant materials

• Reference samples of herbal materials should be made available for use in comparative tests

Packaging materials and labelling

All packaging materials, such as bottles and other materials, should be stored properly

LABELING AND PACKING

All finished drug products should be identified by labeling bears at least the following information:

’

the name of the drug product; a list of the active ingredients showing the amount of each

present and a statement of the net contents the batch number assigned by the manufacturer; the expiry date any special storage conditions or handling precautions that

may be necessary; directions for use, and warnings and precautions that may be

necessary; the name and address of the manufacturer or the company

or the person responsible for placing the product on the market

•

Good Laboratory Practices

• GLP embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, reported and archived.

Scope of GLP• GLP should be applied to the non-clinical safety testing of

test items:

» Pharmaceutical product» Pesticides product» Cosmetic product» Food additives» Feed additives» Industrial chemical

in the Laboratory, in greenhouses or in the field

What Role Do GLPs Play?

Good Laboratory Practice standards help to assure the quality and integrity of studies submitted in support of FDA regulated products

MISSION OF GLP

• Test systems• Archiving of records and materials.• Apparatus, material and reagent facilities.• Quality assurance programs.• Performance of the study.• Standard operating procedures (SOP)• Reporting of study results.• Personnel and test facility organization

Documentation

If you didn’t write it down, it NEVER happened.

Documentation

• Record data using permanent ink (never pencil)

• Date and sign every entry (who is responsible?)

• Keep records in “real time” (no catching up later)

• No rewrites, need original entries (reduces transcription errors)

Documentation is important in all sorts of situations!!

Raw Data

Can you list examples of raw data?• Logbooks (to record temperatures or equipment use,

repair, and maintenance)• Field or laboratory notebooks• Forms (for field or laboratory observations, chain-of-

custody, sample or chemical receipt)• Training reports• Computer printouts• Recorded data from automated instruments

Raw Data

Question:What happens if you make a mistake?

Answer:

Do not obscure original data!! Instead, draw a single strikeout, then add reason code, initials, and date of change. (Preserve the original data).

Standard Operating Procedures (SOPs)

SOPs are written, approved procedures that describe routine activities that are specific for daily operations at each facility.

SOPs should allow appropriately qualified personnel to perform a procedure once trained.

Standard Operating Procedures (SOP)

• They define how to carry out protocol-specified activities.

• Most often written in a chronological listing of action steps.

• They are written to explain how the procedures are suppose to work

Websites

• Code of Federal Regulations (CFR)- all

• EPA GLP Regulations

• FDA GLP Regulations

• USDA- Pesticide Data Program (PDP) Standard Operating Procedures

Thank u