Appendix -2I - LIST OF WHO-GMP; HACCP AND SEI/CMM LEVEL II AND A - Foreign Trade Procedure 2015-2020 (From 5-12-2017 to 31-3-2023) Revised

APPENDIX- 2 I LIST OF WHO-GMP; HACCP AND SEI/CMM LEVEL II AND ABOVE CERTIFICATION AGENCIES A. List of WHOGMP Certification Agencies 1. Drug Controllers/FDA Commissioners of the concerned states B. List of HACCP Certification Agencies 1. The Marine Product Export Development Authority MPEDA House, PanampillyAvenue P.B.No.4272, Kochi- 682036 2. Export Inspection Agencies/Export Inspection Council. 3. Kerala Bureau of Industrial Promotion TC IX/2197, Kurups Lane, Sasthamangalam P.O. Thiruvananthanpuram 695 010 Tel: 0471-2311882; Fax: 0471-2311883 4. QSI (India) Certification P. Ltd. 557, Sector-1, Vidyadhar Nagar Jaipur-302023 Rajasthan Tel. No.0141: 2236895 Fax: 91-141-2236133 E-mail: [email protected] Website: www.qsi.india.com C. List of SEI CMM level II and above certificate issuing authority 1. Customer Relations Software Engineering Institute Carnegie Mellon University Pittsburgh, PA 15213-3890, USA Phone, Voice Mail and on Demand Fax: 412/268-5800 E-Mail:cut [email protected] www.sei.cmu.edu 2. TeraQuest Metrics, Inc P.O.Box 200490 12885 Research Blvd, Suite 207 Austin, TX 78750, USA Phone: 512/219-0286 E-Mail:[email protected] 3. Process Transition International, Inc 106, Archwood P.O.Box 1988 Annapolis, MD 21401, USA Phone: 301/261 9921 Fax: 410/295 5037 E-Mail: [email protected] 4. Global Systems Technology 5811 Amaya Drive, # 204 La Mesa, CA 91942, USA Phone : 619/697-9947 Fax: 619/697-9948 E-Mail:[email protected] 5. Software Technology Transition 60 Elm Street Andover, MA 01810, USA Phone:978/474-4413 Fax:978/475-5432 6. John Ryskowski Consulting 1544, 9th Street Manhattan Beach, CA 90266, USA Phone:310/376-*-8255 E-Mail:[email protected] 7. The Process Group P.O.Box 700012 Dallas, TX 75370-0012, USA Phone:972/418-9541 Fax: 972/618-6283 E-Mail:[email protected] 8. ChangeBridge, Inc. 15103, Gen. Stevens Ct. Chantilly, VA 20151, USA Phone :703/378-0975 Fax: 703/378-0976 E- Mail:[email protected] 9. Theta Information Systems,Inc 555 Lucerne Avenue Tampa, FL 33606, USA Phone : 813/902-0402 Fax:813/902-0258 E-Mail:[email protected] 10. PRT Corporation of America #6 Harbour Industrial estate Bridgetown Barbados, WI E-Mail:[email protected] D. The agencies for ISO (9000) Series ISO 14000 Series have been accredited on further classification of: (i) Quality Management System (QMS)-http://www.qcin.org/nabcb/accreditation/reg.bod qms.php for Quality Management Systems (ii) Environmental Management System (EMS) -http://www.qcin.org/nabcb/accreditation/reg bod ems.php for Environmental Management system under Appendix 2I of the Appendices and Aayat Niryat Forms. Annexure I to Appendix 2I Application Form For Enlistment Under Appendix 2I to Issue Certification and Modification In Particulars Of An Existing Enlisted Agency [FOR WHO-GMP:HACCPAND SEI-CMM LEVEL-2 ABOVE CERTIFICATION] 1. Application for (please tick) (A) Enlistment (B) Modification in particulars of existing Enlisted Agency 2. Name and address of the applicant . (Registered Office in . case of limited companies, . and Head Office . for others ) PIN [][][][][][] 3. Address of all the Branches/ Divisions/ Units/ 1 .. 3 .. located in India if they also to be enlisted PIN [][][][][][] PIN [][][][][][] 2 .. 4 .. PIN [][][][][][] PIN [][][][][][] 4 Details of Accreditation Body from whom the applicant holds a valid accreditation certificate i. Name and Address: ii. Whether the accreditation Body is member : of International Accreditation Forum Yes / No 5. In case the application is for modification in existing enlisted agency, give: Nature of modification required and details thereof . (In case the application is for modification, information in S.No.2 and 3 above will be as per pre-modified status) 6. Particulars of Fees Paid: (i) Bank Receipt/Demand Draft No. . (ii) Amount(in Rs.) (In. figures) . (in words) . (iii) Name of Bank Branch of Issue . 7. Permanent Account Number (PAN) . Issuing authority . Declaration Cum Undertaking for Enlistment in List of Agencies Authorized to issue WHO-GMP: HACCP AND SEI/CMM LEVEL II in Appendix 2I Certification On behalf of M/s _____________________________________________ with its registered / head office located at __________________________________ 1) I hereby certify that I am authorised to sign this declaration cum undertaking. 2) I/We hereby declare that the particulars and the statements made in this application are true and correct to the best of my /our knowledge and belief and nothing has been concealed or held therefrom. 3) I/We full understand that any information furnished in the application if proved incorrect or false will render me/us liable for any penal action or other consequences as may be prescribed in law or otherwise warranted. 4) I/We undertake to abide by the provisions of the Foreign Trade (Development and Regulation) Act, 1992, the Rules and Orders framed thereunder, the Foreign Trade Policy and the Handbook of Procedures. 5) I undertake that the applicant is not a branch/ franchise of a foreign certifying body. 6) I undertake that the applicant has not been de-listed earlier on account of violation of any of the provisions of the FTDR Act, 1992, or any misrepresentation or fraud. 7) That I/we would be liable for the penal action or other consequences as may be prescribed and taken by the Ministry of Commerce or the Directorate General of Foreign Trade for any violation of the undertaking or procedures that are prescribed by the Government. Name:_______________________________ Designation:_______________________________ Address:_______________________________ Contact Nos:_______________________________ Fax:_______________________________ Email:_______________________________ Signature and seal of Agency: _______________________________ List of documents that should accompany the application for enlistment under Appendix 2I 1. Certified copy of valid accreditation certificate for quality management from National Accreditation Board for Certification Bodies (NABCB) or any other agency who is a member of International Accreditation Forum 2. List of firms/companies (whether Indian or foreign) granted certification by the applicant. 3. Declaration cum Undertaking to be given on a stamp paper (Minimum of Two Rupees 4. Fees of ₹ 5000/-(non-refundable) 5. Details on the logistical/infrastructural setup of the agency with regard to: Man power, both Technical and Non- Technical a. Office automation and information technology b. Covered office area 6. Application form is to be submitted in duplicate