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QA abhijit akare ppt

Quality assurance

Chandrashekhar3
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QA abhijit akare ppt

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  1. INSTITUTE :-CHHATRAPATI SHIVAJI COLLEGE OF PHARMACY DEORI DIST GONDIA REPRESENTED BY:- ABHIJIT RAMRAOJI AKARE . SUBJECT :- PHARMACEUTICAL QUALITY ASSURANCE TOPIC :- PERSONNAL HYGIENE ,PERSONAL RECORDS GUIDED BY :- PROF. CHANDRASHEKHAR BADWAIK SIR.

  2. PERSONNEL HYGIENE :-

  3. Hygiene is a series of practices performed to preserve health. • According to WHO hygiene refers to condition and practices that helps to maintain health and prevent the spread of diseases. • Personal hygiene:- refers to maintaining the bodies cleanliness. • The tips or points involved in the personal hygiene are as follows:- • 1) all personal prior to as well as during the period of employment should undergo health checkup for example visual inspection should undergo examination regularly. • 2) all personal should be trained in a practice says of personnel hygiene (that is manufacturing and packaging). • 3) if any person showing symptoms of illness or open lesson should be kept out of the process handling up starting material manufacturing as well as packaging area (illness effect quality of product). • 4) Report the condition of adverse effect of product to their supervisor. • 5) Proper handling care (e. g. Glows in hand with liver handling and caring with compound contact)

  4. 6) wear clean body coverings ---- to avoid contamination of the product. • 7) Eating, drinking, smoking, should be avoided in the production area. • 8) The protocol of personal hygiene should be applied to all persons entering production area. • 9) Person should be instructed to use the hand washing facility.

  5. Personal records:- • These are the records related to employees of the organization and are accumulated , factual and comprehensive information. • All information with effect to human resources in the organization is kept in a systemic order. • Records are helpful to managers in various decision making areas. Proposes of personal records:- • Provide important information to manager regarding the employee. • To keep update to manage salary revisions, allowance and other benefit related to salaries. • Manage designing the training module and development programmed (available information) • Helps to researchers to carry depth study with respect to industrial relations and Goodwill of firm in the market.

  6. Consultant and contract staff:- • Consult regarding the requirement of qualifications for consult and what records need to be kept. • Qualification:- • Qualification for consultant are required same as good for the facility`s employees. • The consultant must have – • -education • -training • -experience • -combination of these in subject for advising • E.g. subject or area of drug manufacturing process-- >then--->knowledge of GMP required. • Records:- • If a company use a consultant then a record of this consultant and services provide must be kept. • The record must contains minimum information- • -consultants name , • -address, • - qualification and • - type of service provided

  7. Consultant and contract staff:- • Each organization should have a training manual specifying the policy and procedures. Types of trainings:- • GMP/GLP related training. • Job related training . • Behavioral training. Training manual records contain:- • Attendance record. • Training evaluation record.

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