1. Preparation, review, distribution, Retrieval and Destruction of all Standard Operating Procedure (SOPs) or any master document in Production, Quality Control, Engineering, Quality Assurance, Store and Personnel & Administration & IT.
2. Identification and control of changes & Deviation through Change Control Form (CCF) & Deviation form respectively applicable to various functions of the plant that affects the final quality and efficacy of the drug product.
3. To give the line clearance for all production areas.
4. To monitor the process and ensure that the batch processing going on as per BMRs/BPRs. Ensure that the BMR is filled up to the stage.
5. To do in process check during processing of products for ensuring the product quality.
6. To do calibration of in process instruments and maintain their records.
7. Preparation & updating of Validation Master Plan (VMP) & Site Master File (SMF).
8. Review the all daily logs maintained in all Departments.
9. Report to Dept Head regarding any Non Compliance Occur during processing if any.
10. Report to Dept Head regarding any deviation occur and take necessary corrective and preventive action and record it.
1. To receive the dispensed materials from Stores and check weight as per BMRs / BPRs.
2. To fill the BMRs / BPRs as per the stages of Production along with the operation.
3. To maintain the Equipment Usage / cleaning log book.
4. To follow GDP in recording the data in BMRs / BPRs and log records.
5. To take the line clearance from QA in case of Product / Batch change over.
6. To take planning for packing from Department Head and implementation the same with prior preparations.
7. To indent packing material and receive the same from the Stores on BPR.
8. To handover finished goods to BSR along with the FGTN properly filled.
9. To perform and supervision all manufacturing activities related to dispensing, granulation, blending, compression and coating under the GMP practice.
10. To reconcile the packing materials and Raw Materials and complete the BMRs / BPRs with all the details entered including yields.
11. To maintain the daily temperature and humidity monitoring, pressure differential record.
12. To ensure availability of Raw Material / Packing Material as per schedule by coordinating with Stores and QC.
13. To resolve small technical problems occurs while processing of product in production.
14. To ensure proper output from every machine and each operation.
15. To ensure cleanliness and avoid contamination and cross contamination.
16. To ensure proper segregation of material with status label at respective stage.
17. To order stereos as per production planning and/or BPR.
18. Co ordinate with QA / Engineering department at the time of equipment qualification activity.
19. To do batch creation in ERP system as per production planning.
20. To send requisition to QA for issuance of BMRs /BPRs.
The tormenting desire to serve mankind and also the ambition to make a dent in one of the fastest... growing Pharma industries is the name ZOTA HEALTH CARE LTD. Now ZOTA is turned into a GROUP with 22 Division in its fold, viz.
To meet the demand of the trade, ZOTA Group can today boldly claim to have over Two thousand eight hundred products in its mix. To free the doctors from the dependence on multiple of companies, ZOTA today offers an unmatched range of products under a single roof. The strength of the natural treatment too has been promoted with separate AYURVEDIC Division.
ZOTA formed the required traits of a truly STANDARD Pharma Organization with the ETHICS of not indulging into unscrupulous practice and unwavering QUALITY with ZERO DEFECT; in fact, ZOTA was approved with the prestigious ISO 9001:2008 Certification & CRISIL SE 1A. This Rating Indicates "HIGHEST" Performance Capability and "HIGH" Financial Strength. In addition to Quality Control, the company has adopted Total Quality Management System, which leaves no stone unturned to keep the product with International Quality Standards.
Our R&D is extensively working on unique and novel formulations especially in nutraceuticals. Already applied 16 unique different formulations for patent and amongs them 7 products is applied for PCT for 142 countries. The formulation which has gone for PCT already introduced in domestic market and accepted by medical fraternity very well. RTFit is a unique and novel combination of two amino acids for liver disorders especially for alcoholic hepatitis with unique mode of action without any complication due to its natural origin. Apart from RTFit other patent applied formulations will be available shortly. Company has already started the clinical trial of RTFit in various liver disorders with good no. of patients to evaluate the efficacy and safety of RTFit.
ZOTA has setup the production facility for the EXPORT at Surat in the Surat Special Economic Zone, Nr. Sachin Railway Station, Sachin, Surat. (Gujarat). This manufacturing plant follows cGMP & WHO conditions comparable with the international regulations (MCC South Africa & MHRA U.K And USFDA.). The company is primarily involved in manufacturing of Tablets & Capsules (General group). Read full description