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Clinical courses

  • A REVIEW ON QUALITY AGREEMENT REQUIREMENT IN PHARMACEUTICALS BY REGULATORY AUTHORITY IN COMPLIANCE TO CGMP GUIDELINES

    { DOWNLOAD AS PDF }

    ABOUT AUHTORS
    Suleman S khoja*1,Sohil S khoja1, Farhad S Khoja2,Shamim S Khoja2, Narmin A Pirani2
    1 Resource person in Pharmaceutical Quality Assurance and Facility Audit,
    Vapi, Gujarat, India.
    2 Registered Pharmacist, Gujarat State Pharmacy Council, Gujarat, India
    *premukhoja@gmail.com

    ABSTRACT
    A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. Quality agreements may be reviewed during inspections. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP. The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP. The most critical pieces are quality and change control, as described in the following sections. Manufacturing Activities Change Control Associated With Manufacturing Activities

  • Walk in interview in QA, Production at Medisol Lifescience

    Medisol Lifescience Pvt. Ltd (MLPL) situated 165 km from Mumbai, near Vapi and located at Vill. Aklara. MLPL is a small scale factory of manufacturing pharmaceutical aerosols. Medisol Lifescience Pvt. Ltd (MLPL) is engaged in manufacturing of antiasthamatic Inhaler products for the treatment of asthmatic patients. We believe in serve to good and quality products to the society.

  • Career Opportunity for QA/QC Executive(05 posts), Production Supervisor(05 posts) in Asian Aerosol | Walk in

    Asian Aerosol OAN Pvt. Ltd. promoted in collabration with Japanese based Daizo company; Australian based Pax company, is looking for potential team members lor new aerosol facility construction for personal care toiletries/ household/ FMCG/ Pharma manufacturing. The One Asia Network is looking to assemble a strong team with a predominantly oharmaceuticai background for project installation & associated QMS implementation along with a strong, successful startup & continued management of tine operations projectedfor trie Vapl/Daman Plant

    Post: QA/QC Executive(05 posts), Production Supervisor(05 posts)

  • A REVIEW ON CHEMISTRY AND PHARMACOLOGICAL ACTIVITY OF METFORMIN HYDROCHLORIDE AND TENELIGLIPTIN HYDROBROMIDE HYDRATE IN COMBINED DOSAGE FORM

    { DOWNLOAD AS PDF }

     

    ABOUT AUHTOR
    Manish Patil*1, Harsha D Jani1, Suleman S Khoja2, Narmin A Pirani3, Shamim S Khoja3
    1Department of Quality Assurance,
    Shivam Pharmaceutical Studies and Research Centre, Anand
    Gujarat, India.

    2Resource person in pharmaceutical quality assurance and Audit Compliance, Vapi
    3Registered Pharmacist, Gujarat, India

    *manishpatil3194@gmail.com

    ABSTRACT
    This review article presents the pharmacology of combined Metformin hydrochloride and Teneligliptin hydrobromide hydrate is effective on type 2 Diabetes Mellitus. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Teneligliptin, a third generation Dipeptidyl Peptidase-4 (DPP-4) inhibitor exhibits unique “J shaped” structure with “anchor-lock domain” mechanism which provides potent & long duration of action. The addition of teneligliptin once daily to Metformin was effective and generally well tolerated in Korean patients with type 2 diabetes. The mechanism of Metformin hydrochloride and teneligliptin hydrobromide hydrate is quite different. The main objective of this review article is to provide pharmacological and Analytical information of combination of Metformin hydrochloride and Teneligliptin hydrobromide hydrate to researcher in development of combined dosage form.

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  • Walk in interview at Sun Pharma in QA, QC - M.Pharm, B.Pharm, B.Sc, M.Sc | only experience candidate

    Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story

    Post : OFFICER / SR. OFFICER / EXECUTIVE

  • IMPACT AND MANAGEMENT TOOL FOR IDENTIFICATION AND REDUCTION OF HUMAN ERRORS IN PHARMACEUTICALS INDUSTRY

    { DOWNLOAD AS PDF }

    ABOUT AUHTORS
    Suleman S. khoja 1 , Sohil S. khoja 1,
    Farhad S. Khoja 2,Shamim Khoja2,Narmin Pirani2

    1)Resource person in pharmaceutical quality assurance and Audit Compliance,VAPI 2) Registered Pharmacist , Gujarat
    Suleman salim khoja
    Email: premukhoja@gmail.com

    Scope 
    Human Error is commonly defined as “a failure of a planned action to achieve a desired outcome”. GMPs clearly state in CFR 211.22 that “[the quality control unit has]…the authority to review Production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.” Let’s analyze this statement. If the FDA expects that errors be fully investigated, it is safe to assume that the term error is NOT a root cause. That’s why it needs to be fully investigated, hence determine the root cause of the human error.  In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations. review article accurately how to accurately identify human errors, determine when a deviation or nonconformance requires CAPA, and get started using human performance improvement tools and processes in your organization.

  • Walk in Interview at Zydus Cadila in Quality Control, Quality Assurance, Packing

    Zydus Cadila is one of India's leading healthcare companies and a global healthcare provider with strengths all along the pharmaceutical value chain. The group’s state-of-the-art manufacturing infrastructure is spread across five states of Gujarat, Maharasahtra, Goa, Himachal Pradesh and Sikkim and the R&D Centers are spread across Ahmedabad, Baroda and Mumbai (Thane).

    Post : Officer/ Executive/ Senior Executive/ Assistant Manager/ Deputy Manager

  • Vacancies in Olive Healthcare | Opening in QA, QC, Production, Regulatory Affairs, Warehouse, Engineering - WALK IN INTERVIEW

    The Olive Group of companies ventured into the world of soft gelatin formulations by setting up its first manufacturing facility over 3 decades ago. Over the years with the advancement and innovation of soft gelatin related technology, and the ever increasing emphasis on cGMP standards, we have set up two state of the art manufacturing units in India.

    We are looking for well qualified .experienced and dynamic! personnel for following positions in our USFDA / EU GMP approved | manufacturing facility at Daman;

    Post: Manager QA, Executive QC, Production Manager, Warehouse, Engineer

  • Walk in interview for QC Officer/Executive at Ajanta Pharma Ltd | 25 Posts

    Ajanta Pharma Ltd, a specialty pharmaceutical company engagi development, manufacture and marketing of quality finished dosaj in domestic and international markets, is looking for suita candidates for its Formulation facility at Dahej, Bharuch, Gujarat

    Post : QC Officer/Executive (HPLC, GC, Micro LIMS)

  • A REVIEW ON USFDA WARNING LETTER AND VIOLATION OBSERVED IN PHARMACEUTICAL INDUSTRY

    { DOWNLOAD AS PDF }

    ABOUT AUTHORS
    Suleman S. khoja 1, Sohil S khoja
    1,Parthkumar H chauhan 2,Farhad S Khoja
    1Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
    2Resource person in quality assurance ,NAVSARI, Gujarat.
    3Registered Pharmacist ,VAPI, Gujarat.
    premukhoja@gmail.com

    ABSTRACT
    A review on USFDA observation and finding while inspection of Pharmaceutical the present review provide some important , Significant observation and measure of compliance.USFDA is an regulatory body governing health products which are made ( in or  outside USA) and marketed in united States of America. Significant deviation from cGMP and Significant violation from cGMP for both API Facility and formulations .strictly compliance requirements under 21 Code of federal regulations (CFR). FDA observation includes but not limited to this. If not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the Safety, Identity, Strength, Purity and Quality of drug product (SISPQ) ,violation under [ 21 CFR & 211.67 (a) ]. Data integrity is main issue Raised in most FDA warning letter. Corrective action and plan. Level of control must be raised from raw material, packaging material (Accurate, Legible, Contamptarious, Original, Attributable (ALCOA)) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification(OOS ) and out of trends(OOT)  must be follow if any required.

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