This document discusses Good Manufacturing Practices (GMP) for Ayurvedic medicines. It outlines the key areas that GMP guidelines cover, including facility location and design, sanitation, quality control, personnel hygiene, equipment and maintenance, documentation and record keeping. The goal of GMP is to ensure safe, effective and quality pharmaceutical products through validated manufacturing and testing practices. Specific requirements covered include water treatment, waste disposal, laboratory controls, personnel qualifications, labeling, and standard operating procedures.

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2. Guided by:
Dr. Vinay R Kadibagil
Professor
Presented By:
Dr.Shobitha Madhur
3rd Year PG Scholar
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Dept of Rasashastra &Bhaishajya Kalpana
SDM College of Ayurveda
Hassan

3.  GMP - set of legal guidelines that have been
regulated by WHO since 1975.
 A production testing practice that helps to
ensure a quality product.
 AIM :
Safe and effective Pharmaceutical products
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4. Location and Surroundings
Buildings
Water system
Disposal of waste
Ware house area
Production area
Ancillary area
Laboratory Controls
Personnel
Equipments
Records
Labeling
SOP
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5.  Away from open sewage, drain, public,
dust, smoke, disagreeable odour
 Free from insects/rodents.
 Adequate light and ventilation
 Floor and wall should not be moist
 It should be according to provision of factory
act
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6.  Treated water sysytem* - for all purpose
 Potable water
 Store in tank – periodic cleaning *
 Provision for waste disposal – according to
pollution control board
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7.  Bio medical waste – Bio medical waste
Management and handling rule 1996*
 Central and state legislation – safe storage
and disposal of waste material*
WAREHOUSE AREA:*
1) Separate sampling area and finished
product area etc
2) Raw material specification - ‘UNDER TEST’
or ‘APPROVED’ or ‘REJECTED’.
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8.  Good quality - selected
 Protected from microbiological contamination
 Proper environmental condition should be
maintained
 It should be stored under different categories
 The licensee shall keep inventory of all raw
materials and maintain records as per schedule
T-A*
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9.  Designed to allow the production preferably
in uni-flow and with logical sequence of
operations
 Pipe-work, electrical fittings, ventilation
openings and similar service lines shall be
designed, fixed and constructed to avoid
[accumulation of dust]
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10.  Rest and refreshment rooms shall be
separate from other areas
 Facilities for changing, storing clothes and for
washing and toilet purposes shall be easily
accessible
 Tools and spare parts for use in sterile areas
shall be disinfected
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11.  Independent of the production areas
 Separate areas shall be provided each for
pharmacognostical, chemical, microbiological
analysis
 The microbiology section shall have
arrangements such as airlocks and laminar
air flow work station, wherever considered
necessary.
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12. Quality control section will have a minimum of –
(i) (a) Expert in Ayurveda or Sidha or Unani - a degree
qualification recognized under Schedule II of IMCC Act
1970;
(b) Chemist - Master Degree in Science or Pharmacy or
Pharmacy (Ayurveda) - recognized University
(c) Botanist (Pharmacognosist) - Bachelor Degree in
Science (Medical) or Pharmacy or Pharmacy (Ayurveda) -
recognized University
(d) Microbiologist - master degree in microbiology
awarded by a recognized university.
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13.  The head of the QC Laboratory shall be
independent of the manufacturing unit
 Qualified and experienced
 Written duties of technical and Quality
Control personnel shall be laid and followed
strictly
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14.  Proper uniform shall be given
 Adequate facilities for personal cleanliness
 Provide facilities for keep there personal
things
 Prior to appointment – personnel shall
undergo medical examination*
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15.  All persons, prior to and during employment -
trained in practices which ensure personal
hygiene
 No person showing, at any time, apparent
illness or open lesions shall be allowed to
handle materials – until proven safe
 All personnel shall wear clean body
coverings appropriate to their duties
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16.  vessels and containers shall be
conspicuously labeled with the name of the
product, batch no., batch size and stage of
manufacture
 Precautions against mix-up and cross-
contamination
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17. SANITATION IN THE MANUFACTURING
PREMISES *
 Cleaned and maintained in an orderly
manner
 A validated cleaning procedure shall be
maintained.
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18.  Located, designed to suit the operations to be
carried out*
 Defective equipment shall be removed from
production and Quality Control*
 Suitable equipment - manually operated/ semi-
automatic or fully automatic machinery made
available
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19.  Documents shall be approved, signed and
dated by appropriate and authorized persons
 Documents shall specify the title, nature and
purpose
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20.  All containers and equipments shall bear
appropriate labels. Different colour coded
labels shall be used to indicate the status of
a product (for example: under test,
approved, passed, rejected)
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21.  ASU products are not released for sale or
supplied before authorized persons have
certified that each production batch has been
produced and controlled in accordance with
the requirements of the label claim and any
other provisions relevant to production
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22.  To evaluate the manufacturer’s compliance
with GMP concept of self-inspection shall be
followed
 Designed to detect shortcomings in the
implementation of GMP and to recommend
the necessary corrective actions
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23.  Packaging records
 Batch packaging records*
 Batch Processing records*
OTHERS*
 SOPs
 Sampling, testing, Records of analysis
 Batch numbering
 Reprocessing and Recoveries
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24.  Record date,manpower,machines,and
equipments should be maintained.
 Record of sale and distribution of each
batch of medicine shall be maintained.
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25.  Validation and process validation
 Product recall
 Complaints and ADR
 Site master files – general information about
the firm and other information in summary
form
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26.  Maintain batch manufacturing record of all
types of product
 List of raw materials, quantities and various
tests with record should be maintained
 Record of manufactured drug to finish
product
 Only after verified and accepted quality it is
cleared for sale
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27.  Packaging materials such as bottles ,jars,
capsules shall be stored properly
 All cleaned and dried before packing the
product
 Finished goods shall be checked in quality
control lab and referred for packing/labeling.
 Dispatched as per market needs
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29. S.No Category
of Medicine
Minimum
manufacturing
space required
Machinery/ equipment
recommend
1 Anjana/Pisti 100 Sq. feet Khalva/mechnised/motorised,khalv
a, End runner/ Ball-Mill
Sieves/Shifter
2 Churna/Nasya K
wath Churna
200 Sq.feet Grinder/ Disintegrator/ Lepa
Pulverisar/ Powder mixer/ sieves.
3 Pills/Vatti/Gutika
Tablets
100 Sq.feet Ball Mill, Mass mixer powder mixer
pill/vati
cuttingmachine,stainless steel
trays/ Containers for Storage.
Driers/Mechanised chattee(for
mixing guggul) where required.
4 Kupi pakva/
Ksara/Parpati/
Lavana Bhasma
Satva/
150 Sq.feet Stainless Steel Vessels/ Flask,
Multani Matti/Plaster
of Paris/Copper Rod,Earthen
container, Muffle
furnace(Electrically Operated)
End/Edge Runner, Exhaust Fan,
Wooden Spatula.
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33.  GMP certificate for Rasaushadhi - State
Licensing Authority only after thorough
inspection by an expert team including
Rasashastra experts nominated by the
Department of AYUSH
 Manufacturing Process Areas
a)Bhatti or Heating Devise Section
b) Grinding, Drying and Processing Section
c) Fuel used
d) Manufacturing area -
toxic fumes like SO2, arsenic and mercury vapour
etc - suitable ventilation and air exhaust flow
mechanism
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34.  Records shall be maintained specially for
temperatures attained during the entire process of
Bhasmikaran
 In Process Quality Control
Shodhan Register
Bhavana and Putta Register
Grinding Records
Packing details
 Product Quality Control
Bhasma pareeksha
 Product recalls
Literature inserted inside the products package -
indicating the name, address of the manufacturing
unit/ email / telephone number for reporting of any
ADR
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37.  A REVIEW OF RASASHALA IN
ACCORDANCE WITH GMP
Dr. Sourav Pal et al, wjpmr, 2016,2(5), 76-82
 Good Manufacturing Practices: A
pathway towards quality ASU medicines
Kaushal Arushi, Int J Ayu Pharm Chem Vol. 2
Issue 1, 2015
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38.  GMP – Globalisation of Ayurvedic
formulation
 Amended due to low standard Ayurvedic
product
 Importance has been given for record
keeping as well as Rasaushadi preparation
 Emphasis is laid on Water system, disposal
of waste
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