quality assurance/gmp in avaleha paka - amam-ayurveda.org

QUALITY ASSURANCE/GMP IN AVALEHA PAKA
DR.R.K.RAI
PRINCIPAL SCIENTIST
DRDC

Avaleha
A Therapeutic preparation with high degree of
Palatability and extended shelf life

Avaleha Paka
A Product of Rasakriya
Phanit Leha Ghana are the simultaneous
stages of Rasakriya

General Methodology of Avaleha Pak
1. Preparation of Decoction/Swarasa
2. Preparation of Pishti
3. Preparation of Syrup with decoction &
Sugar/Jaggery
4. Mixing of Pishti in syrup
5. Mixing of Prakshepa Dravya

Avaleha Paka Lakshana

Steps for Quality Assurance of Avaleha Pak
As per GMP requirement
1. Quality of RM
2. Manufacturing Premises
3. Machinery & Equipments
4. IPQA
5. Product Specification

Quality Of RM
1. Use of Genuine/Authentic RM in textual Ratio
2. Validation of Specs Parameters
2. Validation of Markers/Actives for Authenticity
3. Green herbs should be fresh and mature

Ay. View

Manufacturing Premises
Sanitized, Hygienic and Sterile environment

Ancient Set up of Ay. Pharmacy
Location and surrounding
1. In the east direction of city
2. Nearby to abundance availability of RM
3. Area should be surrounded by orchards

Cont……
Building of the Ayurvedic Pharmacy
1. Walled campus
2. Well ventilated building with windows
and air outlets
3. Separate blocks for different kind of
formulations
4. Proper plantation in the campus

Cont…..
Working division of the Ay. Pharmacy
1. Heating devices in Agneya Kona
2. Grinding/Pulverisation in South
3. Peeling and cutting in Nairitya
4. Cleaning and washing in West
5. Drying in Vayu Kona
6. Vedha Karma in North
7. Storage in Ishan Kona

Cont…..
Supervising staff
1. Pharmacist
2. Pharmacogonist
3. Linguist
4. Accountant/storekeeper

Workers
1. Drug Collector
2. Pharmacy Assistant
3. Security Guard
4. Attendants
As per Schedule T
– Ayurvedic Doctor
– Botanist
– Pharmacist(B.Pharma)
Staff Cont…..

Machinery & Equipments
1. Machinery made up of Stainless.Steel. with
SOP of validation and cleaning
2. With Proper Lid/Cover
3. Dedicated use
4. With status tag

Quality Control of Water
Prevents Microbial contamination
Stable pH for the Product
Prevents HM Contamination

What to be taken care more
1. Processing of product in a sterile condition
2. Mixing of Honey & Prakshepa at appropriate
temperature
3. Filtration of the product with appropriate filters.
4. Immediate packing of the finished product in
suitable containers
5. Quality & Stability assessment of the finished
product

Cont…..
To check the loss of volatiles/nutrients mixing
of prakshepa (Raw herbal powder) at ambient
temperature but care should be taken for
microbial contamination

Ay. Concept for Prakshepa Mixing

Specification of Avaleha should include
1. Description
2. pH
3. LOD
4. Sugar
5. TLC Profile
6. Heavy Metal
7. Microbial Load
8. Ash Values

Critical Factors In specs
1. Organoleptic Characters – Acceptance criteria
in the public
2. Moisture Content
3. Sugar Content
(Both of these have a significant impact on
stability)

Crystallization a major problem
To minimize the chances of crystallization
boiling of Sugar syrup on 105 – 110 0 C for 30 –
45 minutes and use of citric acid in the ratio of
0.2 – 0.5%w/w to achieve the proper inversion
of sugar.

Packing
1. Sterile & Appropriate container
2. Permit minimum possible oxidation of the
product.

Critical Factors for the Stability Assessment
Tail & Ghee – One of the major ingredients
Acid Value & Rancidity should be monitored
during shelf life assessment of the final product

Use of Preservatives
To make sure the protection of food/drug from
degradation the use of following preservative
should be encouraged.
1. Sodium Benzoate
2. Sodium Methyl Paraben
+
3. Sodium Propyl Paraben

Thanks