Impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry

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

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


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.

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.

Career in Bayer as Plant Manager - GMP

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 Executive / Senior Executive, Assistant Manager in Alembic Pharmaceuticals - Only Gujarat experienced candidates

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

Walk in for Trainee Medical Representative in Systopic Labs

Systopic Laboratories Pvt. Ltd. was incorporated in the year 1984 with an objective to provide quality innovative therapeutic solutions. The guiding principle at Systopic is pursuit of  "Excellence through People & Innovation". This dictum forms the basis of all thinking & action at Systopic.
We at Systopic strive hard to retain & build on the goodwill and trust of the medical fraternity, earned by us over a period of 27 years. The basis of which is consistently exceeding customer expectations & keeping patients interest on-top. Practitioners across varied medical specialities patronize our formulations, recognizing our status as a prominent prescription oriented company. There are many "a first time in India" introductions to our credit. Our marketing innovation expertise is well recognized within the industry.

Post: Trainee Medical Representative (Surat, Vapi & Vadodara)