AYUSH STANDARD MARK
What is Ayush Standard Mark?
Quality Council of India has been engaged for voluntary certification of quality of Ayurveda Siddha Unani (ASU) products. Through this scheme, drug manufacturers are awarded the quality seal to the products on the basis of the third-party evaluation of the quality, subject to fulfillment of the regulatory requirements.
AYUSH Standard and AYUSH Premium Marks are awarded for products moving in the domestic and international markets respectively. 146 ASU products are reported to have been awarded AYUSH Premium Mark and 97 products AYUSH Standard Mark.
The Scheme is based on criteria for certification. It has two levels:
a. Ayush Standard Mark which is based on compliance to the domestic regulatory requirements
b. Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with the flexibility to certify against any overseas regulation provided these are stricter than the former criteria.
Benefits of Ayush Standard Mark
Ensure Product Safety
Reputation
Access to new business
Improved efficiency
Customer satisfaction
Helps you stand out from your competitors
Who can be certified Ayush Standard Mark?
Pharmaceutical Industry
Drug Industry
Oil
Liquid
Powder
Syrup
Capsules
Cream/Ointment
Document required for Ayush Standard Mark
- Technical File, Product Master File (TCF)
- Product Testing
- System Manual
- System Procedure
- Policy
- Objectives
- FDA Manufacturing License
- GMP Compliance
- Plant Master File
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
- Mission & Vision
The extent of Documented Information differs as per:
- Product and it's uses
- Composition of the product
Role of Shamkris and Process of Ayush Standard Mark
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
Time Frame
Task
Process
Day 1
Certification Body
Selection
Cost Estimates
- Finding product and it's uses as per Ayush requirements
- Verification of manufacturing site
- Verification of GMP certificate.
- Based on the scope of the product and certification scheme
Week 1
Developing Documents
- Verification of Technical file, Plant Master file and Test Protocol
- Preparation of Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Product Management System
- Ayush Standard Awareness training to QC manager and Production Manager
- Implementing a well-documented manual throughout the life cycle of the product
- Verification of test report as per Ayush guidelines
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to Ayush Standard requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the Certification Body
Week 12
Certification Body
- Ayush Standard certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
AYUSH is an acronym for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy and are the six Indian systems of medicine prevalent and practiced in India and some of the neighboring Asian countries with very few exceptions in some of the developed countries.