Data Integrity Principle Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories should be aware that reverting from automated/computerized to manual / paper-based systems will not in itself remove the need…
Drug product salvaging as per USFDA CFR 211.208 Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Whenever there is a question about whether drug…
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Expiration dating as per USFDA CFR 211.137 (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166. (b) Expiration dates shall be related to any storage conditions stated on…
Stability testing as per USFDA CFR 211.166 (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include: (1) Sample size and test…
General requirements For Laboratory Controls as per USFDA CFR 211.160 (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or,…
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Laboratory records as per USFDA CFR 211.194 (a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: (1) A description of the sample received for testing with identification of source (that is, location from where sample was obtained), quantity,…
Complaint files as per USFDA CFR 211.198 (a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of…
Distribution records as per USFDA CFR 211.196 Distribution records shall contain – The name and strength of the product Description of the dosage form Name and address of the consignee Date and quantity shipped Lot or control the number of the drug product. For compressed medical gas products, distribution records are not required to contain…
Production record review (USFDA CFR 211.192) All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding…
Returned drug products (USFDA CFR 211.204 ) Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored or shipped before or during their return, or If the condition of the drug product, its container, carton, or labeling, as a result of storage or…
Entry And Exit Of Personnel In The Plant OBJECTIVE: To lay down a standard procedure for the Entry and Exit of personnel in the Plant. SCOPE: This SOP is applicable to all employees and visitors entering the plant. RESPONSIBILITY: Security Guard/ Above, Supervisor/Above – Human Resource & Administration, All employees shall be responsible for following…
Induction of New Employees OBJECTIVE: To lay down a standard procedure for the acquaint newcomers with all the systems and procedures of the Company. SCOPE: This SOP is applicable to all recruits RESPONSIBILITY: Officer/Above- Human Resource & Administration shall be responsible for following that procedure. ACCOUNTABILITY: Manager- Human Resource & Administration, Manager- Quality Assurance shall…
Cleaning Of Insecticutor OBJECTIVE: To lay down a standard procedure for cleaning of Insecticutor. SCOPE: This SOP is applicable to all cleaning of all the Insecticutor placed at different locations. RESPONSIBILITY: House Keeper/ House Keeping Supervisor shall be responsible for follow that procedure. ACCOUNTABILITY: Manager- Human Resource & Administration, Quality Assurance shall be accountable for…
Dress Washing, Issue, and Control OBJECTIVE: To lay down a standard procedure for dress washing, issue, and control. SCOPE: This SOP is applicable to all cleaning for the general dress of employees working. RESPONSIBILITY: House Keeping Supervisor/Nominee shall be responsible for following that procedure. ACCOUNTABILITY: Manager- Human Resource & Administration, Quality Assurance shall be accountable…
Medical Examinations of Employees OBJECTIVE: To lay down a standard procedure for Medical Examination of all employees and to ensure are free from any kind of contagious, communicable disease and fit for individual work SCOPE: This SOP is applicable to all the employees working. RESPONSIBILITY: Head- Human Resource & Administration, Concerned Department shall be responsible…
Personnel Hygiene & Cleanliness OBJECTIVE: To lay down a standard procedure for educating the employees about personnel hygiene, cleanliness, and its importance for working in a pharmaceutical company. SCOPE: This SOP is applicable to educate all employees regarding personal hygiene and cleanliness while working. RESPONSIBILITY: Human Resource & Administration and all concerned departments shall be…
Pest And Rodent Control OBJECTIVE: To lay down a standard procedure for pest & rodent control on the premises. SCOPE: This SOP is applicable for pest and rodent control on the premises. RESPONSIBILITY: Representative – Pest Control Agency, Manager – Human Resource & Administration department shall be responsible for following that procedure. ACCOUNTABILITY: Manager- Human…
Preparation of Disinfectant for Uniforms OBJECTIVE: To lay down a standard procedure for preparation and usage of the disinfectant on the premises. SCOPE: This SOP is applicable for the preparation and usage of disinfectants on the premises. RESPONSIBILITY: Supervisor – Housekeeping shall be responsible for following that procedure. ACCOUNTABILITY: Manager- Human Resource & Administration shall…
Recruitment Of Employee OBJECTIVE: To lay down a standard procedure to recruit and appoint the right people in the right place. SCOPE: This SOP is applicable for all recruitments. RESPONSIBILITY: Manager- Human Resource & Administration shall be responsible for following that procedure. ACCOUNTABILITY: Manager- Human Resource & Administration shall be accountable for compliance with this…
Safety and Safety Measures OBJECTIVE: To lay down a standard procedure to aware personnel of safety and safety measures to prevent unforeseen leading to loss or damage to personnel, equipment, and property SCOPE: This SOP is applicable to all employees for education about safety and safety measures. RESPONSIBILITY: Head –All Departments, Manager- Human Resource &…
