1 / 8

Abhay01

https://www.slideserve.com/upload

Chandrashekhar3
Download Presentation

Abhay01

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY, Deori • Subject- Quality Assurance • Topic- Organization and personnel • Presented by- Abhay R. Rahile • Class- 3rd year 6thsem Guided by-Badwaik sir

  2. ORGANIZATION AND PERSONNEL FOR PHARMACEUTICAL INDUSTRY • Personnel • Premises • Equipment & Raw Material

  3. PERSONNEL- • People who work for a large organization • People who are employed by a company or organization • TYPES OF PERSONNEL • Key personnel- • “key personnel are consider those persons in the organization , who have direct impact on the working of the organization & quality of the product produced.”

  4. There are six different key personnel • Head of production department • Head of QC department • Head of QA department • Authorized person • Head of sale & distribution development • Managing director

  5. RESPONSIBILITIES OF PERSONNEL • Authorization of SOP and other documents including amendment • Monitor & control manufacture environment • Plant hygiene • Process validation and Calibration • Design and monitoring storage condition for material & product • Perform and re-evaluate inprocess condition • Monitoring compliance with GMP • Inspection , investigation & taking sample monitor the factor which may affect quality

  6. PERSONNEL TRAINING • Personnel are most signification part of a manufacturing system • Thus , they should be provide with standardized training to maintain a high level of proficiency and competency in work area • It must include • Proper training system • Training requirement must be proper • Training plan of employer should be designed properly

  7. Level Of Training • Initial Training • First level of training to personnel, who is totally new ton industry. • After the training get completed, records should be signed by both the trainee & trainer. • Continuous Training • Continuous training program should be in place to ensure that personnel keep up the skill to carry out their assign taste. • Competency (enhance physical activity) • The overall competency of personnel is a result of education, experience & training. • Upon the completion of initial & competency of personnel should evaluated & documented.

  8. Thank you !!

More Related