General principles of

various Good cultivation,

collection, manufacturing
and storage practices
Made by-
Dr Rachana Kashyap
Pg 1st yr dravya guna
 Introduction
• Goods agricultural and collection practices for
medicinal plants is the only first step in quality
assurance, on which the safety and efficacy of
drug depend upon.
• India has a rich tradition of plant based health
care systems contained in its classical texts like
Charak Samhita and Sushruta Samhita.
• To ensure and enhance the quality of ayurvedic
medicines, the government of India have
notified these guidelines for Good Agriculture
Practices.
Good agricultural practices GAP
• DEFINITION-
It is a cultivation programme design to ensure optimal yeild in
terms of both quality and quantity of any crop.

Guidelines-
1.Soil and climatic conditions-
• Well drained fertile soil
• Best possible environment
• Reliable source of irrigation present
• Availability of shade for shade loving crops.
2. Seeds and propagation material
• Seeds, stem cutting and root cutting are used.
• Seeds should be fresh and free from pests and diseases

3.Crop management for cultivation-

• Field preparation
• Sowing and transplanting

4.Manures and fertilizers-

• Organic manures and vermi-compost are desirable.

5.Irrigation
• Total water requirement of the crop should be estimated in
the light of available agronomic protocol.
6.Crop protection-
• Preventive and control measures should be used for disease,
insect and pest management.
7.Harvesting –
• Harvesting season should be determined and followed.
• Avoiding days of risks like rain, dew, high humidity.
• Containers of harvesting should be clean.
8.Primary processing-
• Cleaning and drying.
9.Packaging, storage and transport.
Good collection practices GCP
• Guidelines on good collection is meant for medicinal plant
produce collected from the wild and seeks to address issues
associated with harvesting and post harvesting management.
Guidelines-
1.Quality considerations-
• Botanical authenticity of species
• Collection of healthy plant
• Harvesting at right phenological stage
• Weather conditions for collection
• Right places for collection
• Sorting of produce
• Foreign matter
2.Environmental considerations-
• Conservation status of species
• Sensitive species
• Distribution of species
• Minimizing harm to source plant
• Habitat management
3.Social considerations-
It consists of fair pricing, benefit sharing , health status of
collectors.
4.Post harvest management-
• Primary processing-cleaning, scrapping ,peeling or brushing as
required and washing with potable water.
• Drying
5.Packaging and storage-
• Protection from heat, humidity and temperature.
• Container of medicinal plant should be labelled properly.
• Each lot of produce should have its shelf life marked.
Good manufacturing practices
GMP
• It is production and testing practice which helps to ensure
quality product.
GMP is mentioned in schedule T of drug and cosmetic rules.
Part 1-
Factory premises-
The manufacturing plant should have adequate space for-
i. Receiving and storing raw material
ii. Manufacturing process area
iii. Quality control section
iv. Finished goods store
v. Office
vi. Rejected goods/drugs store
• General requirements-
1. Location and surrounding
2. Building
3. Drying space
4. Furnace/bhatti section
5. Water supply
6. Disposable of waste
7. Stores –
• Raw material-each container shall be properly identified with
the label which indicates name of the raw material, source,
batch no. or Lot no. and date of receipt.
• Packing material-all packaging materials such as bottles , jars,
capsules etc. shall be stored .
• Finished good –here the quality is checked by experts and
then approved further.
8.Sanitation and hygiene of workers
9.Medical services
10.Batch manufacturing records, distribution records
11.Quality control –tests are made to check standard for
identity, purity and strength as given in pharmacopoeias of
Ayurveda.

Part 2-
It consists of various machinery/equipment recommended
for medicine preparation and manufacturing area or space
required.
e.g. for anjana pisti 100 sq. ft. space is needed and kharel
or end runner like equipment can be used.
Good storage practices GSP
• Proper storage of produce is necessary to maintain potency
and efficacy .
• GSP is useful for manufacturers of medicinal product,
pharmaceutical importers, contractors and wholesalers.
• Storage area-
1.Sufficient capacity for storage of various categories of
material.
2.Clean and dry.
3.Within acceptable temp. limit
4.Written program for sanitation and pest control.
• Material and pharmaceutical product must not be stored
directly on the floor.
• Computerised system used for storage administration have to
be validated.
• Principles for storage is now first expired-first out (FEFO).
• Temperature mapping
• Adequate light
• As for transport, especially the use of dry ice in cold chains is
discussed.