Inspection of Production area for Good Manufacturing Practices

General

• Is the production lit adequately?
• Are the temperature, air filtration and humidity controlled in the areas?
• Is the air pressure in the area appropriate to surrounding areas?
• Is the building for production located and constructed with adequate facilities for operation, maintenance and cleaning?
• Are written instructions for manufacturing and control approved and maintained?
• Do the instructions include formulations, transfer, packaging, filling and in process control methods?
• Is the equipment for transfer, packaging, filling and holding bulk and raw materials cleaned, sanitized and in good condition?
• Are approved materials used in production?
• Is the production area designed in a way to allow unidirectional and logical flow of operations to prevent mix-ups?
• Is there any criss cross flow of men and materials?
• Are the non-storage areas in production used for storage of materials?
• Are there separate and self-contained facilities for production of sensitive products like penicillin, biological preparations, cytotoxic substances, beta lactam and sex hormones?
• Are there separate provisions for storing dirty, cleaned, washed equipment parts and tool room in process storage areas?
• Are the tool room and store room located in way to prevent cross contamination?
• Are the service lines like electrical fittings, ventilation openings and pipe work identified by colors to indicate their direction of flow and nature of supply?
• Are the samples during transfer, packaging, filling or testing are free from contamination by microbes and chemicals?
• Is the weighing of raw materials checked by second person?
• Are the containers holding the materials identified properly?
• During the labelling operations are the labels identified properly?
• Are the major equipment, containers, transfer lines and tanks used for processing and filling are identified to indicate batch designation, contents, pertinent information and control status?
• Are the equipment used for holding, filling, transferring and processing labeled about their identity, control status and batch identification?
• Do the finished products have permanent code marks on their packages?

Ancillary areas

• Are the refreshment and rest rooms separated from the manufacture areas?
• Are there any change rooms or toilets in the plant? Are there separated from the manufacturing area?
• Are protective garments given to personnel entering manufacturing area?
• Is the maintenance workshop separated from production?
• Is a separate area provided for rejected or recalled materials?

Personnel

• Have the personnel undergone eye and medical examination before employment?
• Is there a standard operating procedure for medical examination?
• Is the medical officer qualified to perform medical examination?
• Are the X rays and investigational reports preserved and are the records maintained for medical examination?
• Are the personnel trained to follow personal hygiene?   
• Are the activities in the manufacturing area done under proper approved staff?
• Are the personnel qualified and experienced in analysis and manufacture activities?
• Is a separate gowning procedure followed for personnel entering into manufacturing areas?
• Are the personnel handling beta lactam antibiotics tested for sensitivity for penicillin before employment?
• Are the personnel responsible for handling of cytotoxic substances and potent drugs examined periodically for adverse effects?

Operations and controls

• Are the manufacturing operations approved by a person responsible for productions with a dated signature?
• Are the temperature, air filtration and humidity controlled in the areas where products are handled or exposed?
• Are the containers and contents of vessels used in manufacturing properly labeled with technical staff signature?
• Are the products prepared free from pathogens?
• Do all the areas have independent air locks separately for the entry of men and women?
• Are the various operations done separated from each other?
• Is the processing of various sensitive drugs done in separated areas with proper pressure differentials and independent air handling units?
• Are proper measures to prevent contamination of sensitive products?
• Is there a proper policy for reuse of recovery materials?
• Is there a regular self-inspection system for each manufacturing area?

Sanitation

• Are proper cleaning and sanitation procedures followed according to the SOP?
• Is a validated cleaning procedure followed?
• Does the location permit cleaning of equipment and the area where they are installed?

Records

• Are records maintained for the material type and quantities used?
• Are the documents maintained for processing, transferring filling, sampling and controlling done in manufacturing?  

Production,manufacturing, sanitation, gmp

• mcrhrdi.gov.in
• cdsco.nic.in
• fda.gov