Adequate

no. of qualified personnel Each person should have proper education, training and experience to perform the assigned function Training should be given in the particular operation and cGMP. Training should be conducted by qualified individuals Training should be on a continuing basis

Initial screening individuals should have basic skills like reading, writing, numeracy etc. In addition, they should have proper qualifications degree in pharmacy, microbiology, chemistry, engineering etc Perform a knowledge and skill assessment for each job category Pre-employment screening identifying potential security risks especially if controlled substances would be handled Careful scrutiny of personal and previous employment references Review of possible criminal background

 Once

employed, induction of every new employee should be conducted It should include

Background of the industry Company policies and procedures Basic information about health and

hygiene

This

should be followed by specific job training. Training programs should have appropriate evaluation steps

 Should

be on-the-job appraisal Repeat training should be initiated Education and training records should be maintained Responsibility of training departmental management Audit of training QC department Acknowledgement of achievement by public recognition or remuneration Should also be trained in safety procedures Also in GMP

 Shall

wear clean clothing appropriate to his duties. Protective apparels should be worn Good sanitation and health habits Authorized personnel only should enter limited-access areas If he has an apparent illness or open lesions no direct contact with the product

To avoid any sort of contamination, pharma products have to be produced with clean materials, machines and human beings. Requirements of

health, personal cleanliness, hygiene, protective clothing

should be applicable to all production people, maintenance staff and other visitors.

Health Personal cleanliness Hygienic operations Protective clothing

 Minimum

health requirements of personnel should be written Pre-employment medical test including eye test Yearly health checks If suffering from infectitious disease like cold or conjunctivitis he should not report to work. Supervisory staff should look for signs any symptoms of unhealthy people working in their areas

Should have regular baths Should change clothes frequently Hair should be cleaned Nails should be clipped Use hand washing facilities frequently Male operators should be clean shaven If beard is maintained, it should be covered Women operators minimum make up and no jewellery False eyelashes, false nails, hair pieces,

 Food

and drinks including betel nut/ tobacco should not be consumed in manufacturing or lab areas No smoking Personal medication not permitted Should be trained to keep working area clean and uncluttered Lockers should be clean and tidy.

 No

entry in production area in street clothes Clean working and protective garments covering the head, face, hand shoe and arm Additional devices such as head covering, anti-dust masks, safety goggles Clothing should be laundered at least twice a week Clothing should have no pockets above waist level

Health Personal cleanliness Hygienic operations Protective clothing

 Staff

should not have open wounds, rashes, boils or any skin ailment No upper respiratory tract infections All people working in aseptic areas should be monitored microbiologically Weekly swabs of nose, ear, skin and throat should be taken

 Nails

should be trimmed Should have short and clean hair Shave their beards and moustache No jewellery and make up Staff should be trained in basic elements of microbiology

 No.

of people working in clean and aseptic area should be minimum No unnecessary and jerky movements as it increases bacterial and particulate shedding Maintenance people should also maintain the same level of hygiene

 Special

garment including head and footwear No external pockets Should not shed fibers or particulate matter Should be cleanable and sterilizable Should wear sterilized one or two piece trouser suits gathered at wrists and ankle, high neck. Suitable headgear. Footwear should totally enclose the feet and the bottom edge of trousers should be tucked inside the booties