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 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…
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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…
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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…
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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…
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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 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 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…
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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…
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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…
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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…
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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…
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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 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…
Registration of the samples received by the QC physical-and-chemical and microbiology laboratories for testing OBJECTIVE To provide the registration of samples received by the QC physical-and-chemical and microbiology laboratories for testing. SCOPE This SOP is applicable to the registration of samples received by the QC physical-and-chemical and microbiology laboratories for testing. RESPONSIBILITY Quality Control Analyst…
Physical-and-chemical test analysis analytical reports OBJECTIVE To provide the procedure analytical reports/calculation sheet. SCOPE This SOP is applicable to the the procedure analytical reports/calculation sheet. RESPONSIBILITY Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY QC Head and QA Head shall be accountable for compliance of this SOP. ATTACHMENTS …
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ACCELERATED STABILITY AND SHELF-LIFE CALCULATION Objective: To lay down a method for accelerated stability and to find out the shelf life of the product. SCOPE: To ensure that the procedure method for accelerated stability and to find out the shelf life to the product in pharmaceutical Industries. RESPONSIBILITY: QA and QC personnel shall be responsible…
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The procedure of the control samples keeping To provide the procedure of adherence to the conditions and period of control samples keeping. This SOP is applicable to the procedure of adherence to the conditions and period of control samples keeping. ATTACHMENTS Control sample room entry & exit registration – Attachment-I Control sample: storage and…
The operating procedure of the air sampler in Micro department In Pharma To lay down the operating procedure of the air sampler. This procedure is applicable for microbiological monitoring the air in the production zone with the help of the air sampler. PROCEDURE: General cleaning Clean the surface with a soft cloth, if required, use…
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Record of pressure in the microbiological laboratory in Pharma To lay down the procedure of pressure record in the microbiological laboratory rooms. It is for monitoring the pressure difference between rooms of the lab. PROCEDURE: The pressure difference between the rooms is determined by the laboratory using a manometer Magnehelic. Before the account for the…
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