MAVERICKS ASSOCIATION

Author: Alvina

  • Distribution records as per USFDA CFR 211.196

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    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)

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    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 )

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    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

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    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

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    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

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    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

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    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

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    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

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    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

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    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

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    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

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    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

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    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 &…

  • Upkeep of First Aid Box

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    Upkeep of First Aid Box OBJECTIVE: To lay down a standard procedure for up keeping of first aid box kept inside the company. SCOPE: This SOP is applicable to Human Resource & Administration department for upkeeping the first aid box. RESPONSIBILITY: Manager- Human Resource & Administration shall be responsible for following that procedure. ACCOUNTABILITY: Manager-…

  • Instruction to personnel to report to management about their illness and Open Lesion

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    Instruction to personnel to report to management about their illness and Open Lesion OBJECTIVE: To lay down the standard Procedure for Instruction to personnel to report to management about their illness and Open Lesion. SCOPE: This SOP describes the procedure about instructions to personnel working in the production area to exclude the chances of contamination…

  • SOP for Operating and Cleaning Procedure for Profile Projector

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    SOP for Operating and Cleaning Procedure for Profile Projector To lay down a procedure for Operating and Cleaning procedures for the profile Projector Operating Procedure Switch on the main power supply and panel counter. Switch on the Diascopy illumination switch and the light green halogen bulb will glow on surface of glass plate. Magnification: 10…

  • Procedure of raw water storage and distribution

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    To implement the procedure of raw water storage and distribution. This SOP covers the procedure of raw water storage and distribution. PROCEDURE Ensure that there is no production activity in the concerned area. Visually check the water level in the tank the volume of which is 50m³ If the water level in the tank has…

  • Procedure for operation and cleaning of Insecticutor

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    To lay down a procedure for operation and cleaning of Insecticutor This SOP is applicable for the operation and cleaning of insecticutor in all areas in Pharma Company. RESPONSIBILITY: Respective department personnel, Housekeeping, and Engineering department personnel is responsible for following the procedure mentioned in this SOP. PROCEDURE: Plugin and switch “ON” the insecticutor. Check…

  • Procedure to registrations samples, which enter on analysis in the microbiological laboratory

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    Procedure to registrations samples, which enter on analysis in the microbiological laboratory To lay down the procedure to registrations samples, which enter on analysis in the microbiological laboratory. This operation procedure is applicable for registration of samples, which enter for analysis in the microbiological laboratory. PROCEDURE New incoming material (samples of the finished product, raw…

  • Staff requirements

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    Staff requirements  To provide carrying out of the QC laboratory staff requirements. This procedure is applicable to the QC laboratory staff. PROCEDURE   Permanent staff is to work in the QC laboratory. It must be guaranteed that the staff is qualified, has the motivation, works, and is regulated according to the QC system requirements. The staff…