Vapi

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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.

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

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)

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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.

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen.

Post: Plant Manager - GMP

WALK-IN-INTERVIEW FOR ENGAGEMENT OF HOMEOPATHIC PHYSICIAN & PHARMACIST ON CONTRACT BASIS FOR 1 YEAR ON CONTRACT BASIS  UNDER 'AYUSH'  IN ESIC HOSPITAL VAPI AS PER THE SCHEDULE BELOW:

Post Pharmacist (Homeopathy)

Ind Swift Laboratories is the fatest growing API group . We are having 6+ API Manufacturing Facilities across the globe. We are dealing in regulated market having approvals USFDA, MHRA, TGA.

Post: Jr.Chemist, Sr.Chemist (Production)

Established in 1907, Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.

Post: Executive, Sr.Executive, Assistant Manager