MAVERICKS ASSOCIATION

Tag: Milan

  • Upkeep of First Aid Box

    —

    by

    Alvina
    in

    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

    —

    by

    Alvina
    in

    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

    —

    by

    Alvina
    in

    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

    —

    by

    Alvina
    in

    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

    —

    by

    Alvina
    in

    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

    —

    by

    Alvina
    in

    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

    —

    by

    Alvina
    in

    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…

  • Physical and chemical quality Control test of potable/raw water

    —

    by

    Alvina
    in

    Physical and chemical quality Control test of potable/raw water The procedure of potable/raw water quality control test.  Raw water analysis report:     Attachment-I Raw water analysis protocol:  Attachment-II PROCEDURE   Use a 500 ml vessel with a stopper for sampling. On the vessel write the name of sample, place and date of sampling.  Allow water to…

  • Procedure for sampling of material for microbiological analysis

    —

    by

    Alvina
    in

    Procedure for a sampling of material for microbiological analysis  To lay down the procedure for the sampling material for microbiological analysis. This SOP is applicable for the sampling of material for microbiological analysis. PROCEDURE: Sampling procedure Sample the material as per the sampling plan. The sampling device should be sterilized by autoclaving or thoroughly wiped…

  • Testing and reporting of in-process unpacked products

    —

    by

    Alvina
    in

    Testing and reporting of in-process unpacked products OBJECTIVE  To provide the procedure of testing and reporting of in-process unpacked products. SCOPE  It is applicable to the procedure of testing and reporting of in-process unpacked products. RESPONSIBILITY  Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY  QC Head and QA…

  • Structural working in the physical-and-chemical laboratory

    —

    by

    Alvina
    in

    Structural working in the physical-and-chemical laboratory OBJECTIVE  To lay down a procedure for the structural working in the physical-and-chemical laboratory.  SCOPE  This SOP is applicable for organization of work in the physical-and-chemical laboratory. RESPONSIBILITY  Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP.  ACCOUNTABILITY  Quality Control and Head QA Head…

  • Procedures for organizations and undertake microbiological tests

    —

    by

    Alvina
    in

    Define procedures for organizations and undertake microbiological tests and the checking the applicable methods. The acknowledgment of the validity of the methods of the work. PROCEDURE: In conducting research in the microbiology laboratory staff must adhere to the established regime and anti-epidemic work rules. Persons permitted to work in the microbiology laboratory only those who…

  • Operation & Cleaning of Lift in Warehouse

    —

    by

    Alvina
    in

    Operation & Cleaning of Lift in Warehouse Objective: To lay down a procedure of operation & cleaning of lift in the warehouse. Scope: This procedure is applicable into warehouse . Responsibility: Warehouse supervisory staff shall be responsible for operation and cleaning of Lift. Accountability: Head Warehouse shall be accountable for implementation and compliance of this…

  • Procedures and Specifications for Media Fills

    —

    by

    Alvina
    in

    Procedures and Specifications for Media Fills The procedures and specifications used for media fills shall be described Summaries of results for validation using the same container- closure system shall be described Filling process that is to be used for the product should be described. The microbiological testing method(s) used should be described. Any procedural differences…

  • AUTOCLAVE – MAINTENANCE AND VALIDATION

    —

    by

    Alvina
    in

    AUTOCLAVE – MAINTENANCE AND VALIDATION Qualification and Validation With such importance placed on the autoclave how can the user be certain that it has achieved the required sterilization? As an autoclave operator involved in your manufacturing process – or as a laboratory operator – you are responsible for your manufacturing process or for the results…

  • Changes as per SUPAC Guideline Part -I (components or composition)

    Changes as per SUPAC Guideline Part -I (components or composition)

    —

    by

    Alvina
    in

    Changes as per SUPAC Guideline Part -I (components or composition) During the post-approval period, to change: 1) The components or composition 2) The site of manufacture 3) The scale-up/scale-down of manufacture. 4) The manufacturing (process and equipment) of an immediate release oral formulation. The guidance defines: 1) Levels of change 2) Recommended chemistry,manufacturing, and controls…

  • Operational Qualification of Fluid Bed Processor In Pharma

    Operational Qualification of Fluid Bed Processor In Pharma

    —

    by

    Alvina
    in

    Operational Qualification of Fluid Bed Processor In Pharma Operational qualification is the process of demonstrating that Fluid Bed Processor will function according to its operational specification in the selected environment. All the  operation of Fluid Bed Processor t is verified by performing the test functions,• A conclusion is drawn regarding the operation of Fluid Bed…

  • Film Coating By by design of experiments

    Film Coating By by design of experiments

    —

    by

    Alvina
    in

    Film Coating By by design of experiments To identify and screen the critical process parameters by design of experiments and optimizing it using the “Environmental Equivalency” (EE) factor. Film-coating of tablets has many variables and the factors like core tablet composition, coating equipment, process conditions and coating suspension, influence on quality and visual appearance of…

  • SOP for Responsibility of Compounding Personnel in sterile preparation

    SOP for Responsibility of Compounding Personnel in sterile preparation

    —

    by

    Alvina
    in

    SOP for Responsibility of Compounding Personnel in sterile preparation Compounding personnel is responsible for ensuring that Compounding sterile preparations (CSPs) are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper…

  • Documentation for Manufacture of Pharma Sterile Products

    Documentation for Manufacture of Pharma Sterile Products

    —

    by

    Alvina
    in

    Documentation for Manufacture of Pharma Sterile Products The Documents relating to the manufacture of sterile products shall be as follows but not limited to these documents only: – (1) Serial number of the Batch Manufacturing Record. (2) Name of the product. (3) Reference to Master Formula Record. (4) Batch / Lot number. (5) Batch /…