GuidelinePharma

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…

Production

Procedure of raw water storage and distribution

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…

Warehouse

Procedure for operation and cleaning of Insecticutor

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…

Production

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

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

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

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

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

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

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

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…

Microbiology

Operation & Cleaning of Lift in Warehouse

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…

Production

Procedures and Specifications for Media Fills

August 4, 2022February 11, 2023 Alvina

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…

Production

Cleaning Of Building Premises

July 26, 2022May 21, 2023 Alvina

Cleaning Of Building Premises OBJECTIVE: To lay down a standard procedure for the cleaning of building premises. SCOPE: This SOP is applicable for cleaning of entire Premises (Administration office, Utility, Security, Panel room, Change rooms, Toilets, Stairs, and Corridors, and outside areas including roads) . RESPONSIBILITY: Supervisor/Above – House Keeping and Human Resource & Administration…

WHO INSPECTION & REQUIRED DOCUMENTS

July 22, 2022February 17, 2023 Alvina

WHO INSPECTION & REQUIRED DOCUMENTS Objectives of a manufacturing site inspection The overall intent of a manufacturing site inspection is to assess the safety, performance, and quality of the Manufacturing site. The specific objectives are to assess compliance of the manufacturer’s quality management system (QMS) and manufacturing practices with international standards in order to: Determine…

AUTOCLAVE – MAINTENANCE AND VALIDATION

July 10, 2022February 11, 2023 Alvina

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…

Production

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

July 6, 2022May 21, 2023 Alvina

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

June 23, 2022February 11, 2023 Alvina

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…

Production

Film Coating By by design of experiments

June 21, 2022February 11, 2023 Alvina

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…

Production

Quality Assurance Policies and QMS Procedure

June 20, 2022February 11, 2023 Alvina

Quality Assurance Policies and QMS Procedure Quality Assurance Policies Document and Data Control Policies Cleaning and Sanitization Policies Personnel Hygiene Policies Environmental Control Policies Pest Control Policies Training Policies Risk assessment policies Validation Policies Vendor Policies Quality Management System Site Master File Validation Master Plan Quality Manual, SOPs STPs Specifications Quality Management Procedures Change Control…