GMP Compliance India
| About us | (scope: Cgmps; glps; ISO:9001; computer system validation; software quality; haccp& biotechnology)- Can conduct cgmp based qa compliance audits on your raw material suppliers and contract manufacturers in and around india saving for your organization valuable time, effort and expenses Objective: Is (i) to be your virtual business associate in india performing the duties connected with assessment and inspection of quality system and other capabilities of the subcontractors and raw material suppliers. (ii) to be your retained representative in india and apprise you of the current developments in your raw material suppliers/subcontractors status-que related to the maintenance of quality of processes that can affect the quality of the product. (iii) to be your retained representative in india to oversee that right quality of material is expedited within the stipulated time frame. The benefit you get out of us: We can be your retainer-representative as qa associate in india to conduct cgmp/ISO:9001 qa compliance audits at your prospective suppliers/subcontractors& check product quality just before packaging& shipment About us: We can help the finished dosage/api buyers from any part of the globe who wish to buy their material from indian manufacturers. Our help to people like you starts from sourcing out good suppliers from india, assessing their quality mangement systems& documentation along with implementation. We can conduct-on your behalf- an indepth quality system audit and verify whether the prospective supplier/sub-contractor is adhering to the norms of good manufacturing practices [or] not. Our verification also includes the check on conduct of on-site operations whether they are based on validated proceedures [or] not. Our inspection also highlights whether the measuring instruments used are calibrated from time to time [or] not. And other things like: Inward inspection ;inprocess inspection ;qa ; dealing with -oos Sanitation& cleaning and personnel hygein. Label accessability ; control& reconcilation Storage& dispatch apart from many others. Totally professional approach: Yes. Backed by expertise in conducting more than 400 quality system audits on indian and multi [trans] national organizations. Yes. By adhering to clear judgements and very high order integrity. Yes. Being highly qualified chemical engineer with many years of experience in pharma sector- with additional ability to deal with complicated processes like bio-technolgy/fermentation etc. Yes, by checking the computer system validation How can we help you? By conducting quality system audits on your supplier s premisses at predefined frequency, based either on your audit checklist or our pre- approved checklist. By overseeing their analytical procedures for those production batches meant for shipping as against your purchase orders. By being your representative and seeing the expedition of right material in right time By being your eyes, your think tank and a part of you in india. Interested? Need such an important service assistance in india? |
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| Industry Focus | Pharmaceutical Chemicals, Food Additives, Bio-technology Products |
| Products/Services | We Conduct GMP based Quality system inspection on raw material suppliers in and around India. |
| Our Markets | Western Europe |
| No. of Employees | 5 - 10 People |
| Annual Sales Range(USD) | Below US$1 Million |
| Year Established | 1999 |
| Legal Representative(CEO) | Krishna Das, Mukteevi |
