Central Inspection Plan Using Risk Based Approach Of Vaccine Manufacturing Units for 2017
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1 , follow-up, failure A NORTH ZONE 1 M/s Biomed Pvt. Ltd, C-96, Site I, Bulandshahar Road, Ind. Area, Ghaziabad. 1. Oral Polio Vaccine IP, 2. Vi Typhoid Vaccine (Bio Typh TM ) IP, 3. Haemophilus Type-B Conjugate Vaccine (PedaHib) 4. Meningococal Vaccine (Group A,C,Y,W 135) QuadriMeningo 5. Meningococal Vaccine (Group A&C) Bivalent 6. Vi Conjugate Typhoid Vaccine (Peda Typh), 7. Vi Conjugate Typhoid Vaccine (Bio Typh TM ), 8. Haemophilus Type-B Conjugate Vaccine (PedaHib) IP 9. Meningococal Sep 2016 by CDSCO & State Inspector. Follow up 3 rd Quarter Page 1 of 12
2 , follow-up, failure 2 M/s Pan Era Biotec Pvt. Ltd, Ambala Chandigarh Highway, Lalru, Punjab. Vaccine (Group A,C,Y,W 135) IP QuadriMeningo 10. Meningococal Vaccine (Group A,C,Y,W 135) Ph. Euro QuadriMeningo 11. Meningococal Vaccine (Group A&C) Bimeningo 12. Meningococal Vaccine (Group A,C,Y,W 135) QuadriMeningo, Nm Vac-4 ACYW Veterinary. Hepatitis B Vaccine (r DNA) IP (Bulk), Hepatitis B Vaccine (r DNA) BP (Bulk), Hepatitis B Vaccine (r DNA) Bulk drug substance & 27& 28 Sept 2016 by CDSCO, State Inspector & expert from CDL, Kasauli Follow up Inspection of the previous joint Yes, compliance met Page 2 of 12
3 , follow-up, failure 3. M/s Panacea Biotec Limited, Malpur, Baddi, Tehsil- Nalagarh, Distt. Solan, Himachal Pradesh. Haemophilus Type b Conjugate (PRP - TT) BP (Bulk). Bulk purified Diphtheria Toxoid (D), Bulk purified Tetanus Toxoid (T) Pooled Bulk of Whole Cell Pertussis (WP). Recombinant Hepatitis B Vaccine IP/BP, DTwP- Hib(Easyfour), DTwP-Hib- Hepatitis B (Easy five), DTwP-Hib-TT (Easyfive), DT wp-hepatitis B (Ecovac-4), Hep B (Enivac HB), Hib (Novohib), Salk based IPV Vaccine (Polprotec), Haemophilus type b conjugate vaccine BP, Pandyflu & Nov 2016 by CDSCO & State Inspector and Kasauli For grant of additional products and renewal of GMP Certificate Communicate. Follow up Inspection 4 th Quarter Page 3 of 12
4 , follow-up, failure DTwP 4 Bharat Immunological s & Biologicals Corporation Limited (BIBCOL), Village Chola, Dist. Bulandshahar, U. P. 1. Trivalent Oral Poliomyelitis Vaccine IP 2. Bivalent Oral Poliomyelitis Vaccine Sabin strain (Type-1 & Type 3) Nov 2016 by CDSCO & State Inspector and Kasauli Routine along with of the earlier. Follow up 4th Quarter 5 M/s Central Research Institute Kasauli, Distt. Solan (HP) Diphtheria, Tetanus & Pertusis Vaccine (Adsorbed), Concentrated Diphtheria, Tetanus Pertusis Vaccine (Adsorbed), Tetanus Vaccine (Adsorbed), Diphtheria & Tetanus Vaccine (Adsorbed) Dec 2016 By central, state Drugs inspector and expert from CDL Kasauli Routine and Follow up for the previous. Follow up Page 4 of 12
5 , follow-up, failure B SOUTH ZONE 1 M/s. Green Signal Biopharma, Pvt. Ltd., 49, Pappankuppa m Village, Gummidipoon di, Chennai BCG Vaccine (Freeze-Dried) IP/BP/EP/USP 2.BCG for immunotherapy (Freeze dried) BP/EPP Dec.2016 By central, state Drugs inspector Kasauli Follow up of the earlier along with grant of post approval changes and renewal of GMP certificate 3 rd Quarter along with of the earlier 2 M/s Human Biologicals Institute (A division of Indian Immunological s Limited) Kozhipannai, Pudumund Post, Udhagamandal am Tamil Nadu Rabies Vaccine, Human IP, BP, Purified Rabies bulk antigen Dec 2016 by CDSCO and State Inspector Follow up Inspection No 4 th Quarter along with of the earlier Page 5 of 12
6 , follow-up, failure C WEST ZONE M/s. Serum Institute of India Ltd, 212/2 Hadapsar, Pune M/s. Haffkine Biopharmaceu tical Corporation Ltd. ( HBPCL), Parel, Mumbai M/s Glaxo Smith Kline Asia Pvt. Ltd. Nasik TT, DT, DPT, Rabies, Hib, Meningococcal A Conjugate vaccine, Influenza vaccine, BCG, Measles, Rubella, MMR,flu vaccine for TT,DTP HiB, DTP HiBHep.B, Rabies vaccine,h1n1 OPV Labeling and packaging of Inactivated Hepatitis A, Typhoid Vaccine, Rotavirus, DTP, DTP+ 06 Oct 2016 by CDSCO and State inspectors Oct 2016 by of CDSCO, State 16 June 2016 by of CDSCO and State inspectors For utilization of cold room facility WHO observed audit NRA Assessment Renewal of mfg. license Yes, compliance met Yes, compliance met Follow up 4 th Quarter Page 6 of 12
7 , follow-up, failure Hepatitis B, D HYDERABAD 1 2 Bharat Biotech International Ltd. Genome Valley, Turkapally Shameerpet (Mandal) Hyderabad Biological E. Limited Gaganpahad Rajendra Nagar Mandal, R.R., Dist., TS. Hepatitis B vaccine, VI Typhoid vaccine, Hib, DTP+Hib+Hep, Rabies vaccine Dedicated bulk antigen facility of TT August 2016 by CDSCO, State September 2016 by CDSCO, State inspectors and expert from CDL, Follow up Inspection 4th Quarter Annual Inspection Annual Inspection along with Follow up Inspection Page 7 of 12
8 , follow-up, failure 3 M/s Human Biologicals Institute (A Division of Indian Immunological Limtied) Rakshapuram, Gachibowli, Hyderabad , TS Hepatitis B vaccine, Tetanus Toxoid vaccine (Adsorbed), DTP vaccine 4-5 March 2016 by CDSCO, State Follow-up Inspection 3rd Quarter Annual Inspection 4. M/s Human Biologicals Institute Survey 281 to 284 and 321, Karakapatla (V), Medak ,TS Inactivated Rabies Vaccine September 2016 by CDSCO, State inspectors and expert from CDL, For Annual audit using risk based approach Annual Inspection along with of earlier 5 M/s. Biological E. Limited 18/1 & 3,Azamabad, Hyderabad, TS DTP bulk, JE Vaccine bulk, TT, bulk Aug 2016 by CDSCO, State Follow up Inspection 4 th Quarter Annual Inspection Page 8 of 12
9 , follow-up, failure 6 M/s. Dano & Biological Pvt. Limited, 575, Sivareddyguda, GhatkesarMan dal, R.R. Dist Dedicated bulk antigen facility of TT & by CDSCO, State along with Follow up Inspection of the earlier 7 8 M/s. Biological E. Limited, Plot no. 1, SP Biotechnology Park Phase II, Kolthru village, Shamarpeet, Madal, Ranga Reddy, Dist., TS. M/s. Shantha Biotechnics Ltd. Survey 274, Arthvelli Village, DTPw (Whole cell), Diptheria, Pertusis Hepatitis B vaccine bulk, JE Vaccine, TT, Hepatitis B, DTP+ Hep+Hib Hepatitis B vaccine, DTP, DTP+Hepatitis B, DTP+ Hepatitis +Hib, TT, Hib, DTP+Hib, Oral August 2016 by CDSCO, State 20 Aug 2016 by CDSCO, State For verification of the status of the GMP compliance and factual status of reported NSQ Investigation completed and reported Follow up 4th Quarter Page 9 of 12
10 , follow-up, failure MedchalMand al, Ranga Reddy District, Andhra Pradesh Cholera Vaccine, Hepatitis B vaccine bulk, DTP bulk, TT, TT bulk, DTP+ Hep+Hib bulk 9 M/s. Shantha Biotechnics Ltd., Sy. 354, Muppireddypa lly (V), Toopran (M), Medak Dist, T.S. TT Antigen and TT Carrier & DI, CDSCO, Hyd, Expert, CDL, Kasauli and AD, DCA,TS & DI, DCA, Hyd, TS. For Grant Inspection & For Post Approval Changes NA NA 1st Quarter 3rd Quarter Follow-up Inspection () E AHMEDABAD 1 M/s Cadila Healthcare Limited, Sarkhej- Bavla, NH-8A, Village Moraiya, Dist. Ahmedabad License G/Vac-1 in Rabies Vaccine 11 &12 July,2014 by CDSCO, State Routine as per Central Inspection Plan Annual Inspection along with of the earlier Page 10 of 12
11 , follow-up, failure form 28-D dated 10/11/ M/s Cadila Healthcare Ltd. Village Changodhar, Tal Sanand, Dist Ahmedabad Lic. G/28D/Vac/03 Dated M/s Chiron Behring Vaccine Ltd., Plot 3502, GIDC Estate, P.O. 136, Ankleshwar, Gujarat License in form 28- D/G/LVP-2, dated 20/06/2001 Inactivated Influenza Vaccine ( Monovalent Vaccine, Trivalent Influenza and etravalent (Split Virion) I.P. Single Dose (Embryonated hen eggs derived) Rabbies Vaccine 11-12August, 2016 by CDSCO, State October, 2016 by CDSCO and State inspectors Grant of additional product Post approval change and As per Report Yes, compliance met Annual Inspection Annual Inspection along with of the earlier Page 11 of 12
12 , follow-up, failure Note: 1. Additionally, Inspections for selected prequalified vaccine facilities shall be planned as and when Inspections are planned by WHO for prequalification and Central Inspection Plan shall be updated accordingly. 2. Further it is pertinent to mention that all biological products s for other than investigation/grant/renewal of license, shall be carried out usually once in a year, unless otherwise justified based on risk based analysis of the firms, products and issue requiring as per Directorate Office Memorandum no File No X-11026/143/16-BD dated Page 12 of 12
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