GQS provides AYUSH Consultancy, AYUSH Certification assistance, AYUSH Training, AYUSH documentation. Located in Kerala, Tamilnadu, Karnataka or Maharastra and looking for AYUSH Consultant drop an email to shakti@gqsindia.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or shaktinayak@yahoo.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it
or alternatively reach us on +919845313910
VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS
Process: Ayush Product Certification
STEP I Planning by Organisation for Ayush Product Certification
Organisation identifies the Criteria for certification.
STEP II Preparation by Organisation
1. Obtain the relevant applicable legal documents based on selected certification criteria e.g. Domestic Regulations under the Drugs and Cosmetics Act, GMP Requirements based on WHO Guidelines, Levels of Contaminants, and Regulations of the importing country etc
2. Assess and prepare yourself so as to ensure that the processes and the Ayush product being manufactured would comply with the requirements of the relevant Certification Criteria.
3. Install inhouse testing facilities if seeking certification for Ayush Premium Mark.
4. Confirm that your production facility has been in production for at least one year.
5. Verify that five commercial batches of the products of dosage form for which certification is being planned to be sought, have been manufactured during the current licensed period.
STEP III Self assessment by Organisation:
1. Review your own current systems and practices against the requirements (applied Certification Criteria) and ensure compliance prior to applying for product certification.
STEP IV Select a Certification Body:
drop an email to shakti@gqsindia.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or shaktinayak@yahoo.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or alternatively reach us on +919845313910 to identify your AYUSH certification body
STEP V a. Registration by a Certification Body
1. The certification body will examine your application, shall contact you for any clarification if required.
2. Once the application is concluded by certification body as complete and adequate, the certification body shall determine the duration of the evaluation at your site, based on the number of products to be certified, the manpower, the complexity of operations and processes, and availability of lab.
3. Certification body shall send quote to you.
4. On acceptance of its quote by the organisation, the Certification body shall in consultation with organisation finalize the dates for evaluation.
STEP V b. Evaluation by a Certification Body
1. The certification body will carry out the evaluation in one stage for Ayush Standard and in two stages for Ayush Premium Mark. During the Stage 1 evaluation, state of preparedness, status of GMPs and availability of competent personnel and equipment for production and testing will be assessed for their adequacy.
2. If Initial Evaluation is not carried out within six months of registration of application, the application and registration stand automatically closed. Applicant to start with fresh application and certification process.
3. If more than 20% of samples fail on factory testing during the Initial Evaluation
the application and registration stand automatically closed. Applicant to start with fresh application and certification process.
4. At the end of Stage 1 evaluation the Certification Body will inform the organisation in writing about the deficiencies observed, if any, with respect to the certification criteria. Take necessary actions and inform the certification body as soon as possible but not later than 3 months of the Stage 1 Evaluation. Delays beyond this will lead to another Stage 1 evaluation of your facility by the certification body.
5. In case of non acceptance of internal quality assurance protocol by client within a month of Initial Evaluation, the application and registration stand automatically closed. Applicant to start with fresh application and certification process.
6. The certification Body will undertake the Stage 2 evaluation only after you have confirmed that necessary actions on the identified shortfalls have been taken. For the stage 2 evaluation the certification body will visit the facility and evaluate the process and controls being implemented, the prevailing hygienic conditions, the testing facilities and the competence of the personnel for compliance to the certification criteria.
7. The certification body will draw samples of products from stocks that are representative of normal production capacities of the facility, and have the same tested in an independent laboratory accredited by NABL, for compliance to the certification criteria.
STEP VI Follow up and Corrective actions
1. If more than 20% samples fail on factory testing during the follow up evaluation,
the application and registration stand automatically closed. Applicant to start with fresh application and certification process.
2. At the end of Stage 1 or 2 evaluation the Certification Body will inform the applicant in writing of the deviations observed, if any, with respect to the certification criteria.
3. Organisation shall take necessary actions and inform the certification body as soon as possible. If not shown progress towards completion of corrective actions within three months of Initial Evaluation your application shall be closed.
4. If testing facilities are not completed within three months of Initial Evaluation, or
else arrangements for testing for specified requirements in NABL accredited laboratories have not been made, the application and registration stand automatically closed. Applicant to start with fresh application and certification process.
5. If the corrective actions can be verified through documented evidence, you will be required to provide the same to the Certification Body for verification of corrective actions. However if verification of corrective action is to be undertaken at the manufacturing site or if a follow up evaluation is required is only possible at site, the Certification body evaluator visits the site for confirmation of the identified corrective action only or for follow up of non conformities identified during the previous evaluation.
6. If the sample drawn fails on independent testing, you will be informed of the same and advised to take necessary corrections for improving the product quality. After taking the corrective actions, you must re-offer the products for sampling and testing by the certification body. The Certification body plans another visit to the site, verifies the corrective actions taken by the organization and draws the fresh sample from a stock of material that is representative of the normal production capacity of the organization.
NOTE: At any point of audit stage wherein following conditions are noticed, the application and registration shall be closed,
* Lack of competent personnel for production and testing,
* Misuse of Ayush Certification Mark
* Evidence of malpractice
* Voluntary withdrawal of application.
STEP VII Certification decision
1. The Certification Body will review Stage 1, Stage 2 evaluation reports, corrective actions, relevant documentation, and the independent test report(s) in order to make a certification decision. The decision for certification will be taken only when all requirements of the Scheme have been complied with.
2. Certificate shall be awarded to the manufacturer only for the range of products applied for and offered for evaluation and testing.
3. The Certificate shall be awarded for fixed time tenure of 3 years, during which your operations and the products will be subjected to surveillance evaluations and testing, and beyond the 3 years period of validity the certificate will be renewed subject to ongoing compliance
4. The certification process should be completed within 12 months of the registration of the application (contract signing date with the certification body) failing which the certification body would reject your application.
STEP VIII Issue of a Certificate by Certification Body
1. The Certification Body issues a certificate to the manufacturer indicating relevant certification criteria have been met.
2. The name of the manufacturer with address of site, names of products, and the relevant certification criteria are clearly mentioned on the Certificate, along with effective date of certificate, validity of the certificate, name and address of the Certification Body and applicable logos.
3. The certificate are issued within 7 days of the certification decision and informed to the QCI about the grant of product certification.
STEP IX Agreement for usage of Ayush Certification Mark(s)
1. To apply for authorization for affixing the applicable Ayush Certification Mark on Ayush products contact QCI secretariat.
STEP X Maintaining Certification
1. Ensure that the products certified under the Scheme continue to comply with the Certification criteria.
2. Implement Internal Quality Assurance Protocol provided by the CB and maintain records.
3. Inform production schedules to the CB when asked for
drop an email to shakti@gqsindia.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or shaktinayak@yahoo.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it or alternatively reach us on +919845313910 to identify your AYUSH Consultant, AYUSH Consultancy, AYUSH Certification assistance, AYUSH Training, AYUSH documentation.
