SOP for Responsibility of Compounding Personnel in sterile preparation

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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…

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Quality Assurance

Documentation for Manufacture of Pharma Sterile Products

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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 /…

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Production

SOP for Out of Specification (OOS)

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SOP for Out of Specification (OOS) SOP for the procedure for handling, investigating, and reporting test results, which do not meet the specification.  This SOP is applicable to all out of specification results during the analysis of raw materials, packaging material, finished products, stability study samples, and any unusual results observed for test parameters This…

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Quality Control

Registration of the samples received by the QC physical-and-chemical and microbiology laboratories for testing

Posted on By Alvina

 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…

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Microbiology

Physical-and-chemical test analysis analytical reports

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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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Quality Control

ACCELERATED STABILITY AND SHELF-LIFE CALCULATION

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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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Quality Control

Procedure of the control samples keeping

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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…

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Quality Control

Operation and calibration procedures of gas chromatograph

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Operation and calibration procedures of gas chromatograph To provide the operation and calibration procedures of the gas chromatograph. Is applicable to the operation and calibration procedures of gas chromatographs. The quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP. QC Head and QA Head shall be accountable for compliance with…

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Quality Control

The operating procedure of the air sampler in Micro department In Pharma

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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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Microbiology

Record of pressure in the microbiological laboratory in Pharma

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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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Microbiology

Operation of pass box transferring of materials in Microbial lab of Pharma Industry

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Operation of pass box. transferring of materials in Microbial lab of Pharma Industry To lay down the pass-box operation procedure. This procedure is applicable when passing the material from one room to another using the pass-box. PROCEDURE: General cleaning After use, wipe the inside of the folded-box clean dry rag. After completing the mechanical cleaning…

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Microbiology

Safety working in the microbiological laboratory In Pharma

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Safety working in the microbiological laboratory In Pharma Providing a safe work environment to employees. The personnel of the microbiological laboratory. PROCEDURE: To work in the laboratory allowed a person for a recent preliminary medical examination, an introduction, and initial instruction in the workplace on occupational safety, special education, if necessary (including safety), and validation…

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Microbiology

Requirements to personnel of the miсrobiological laboratory

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Requirements for personnel of the miсrobiological laboratory Set requirements to personnel  of the microbiological laboratory Determine the qualifications of personnel, their rights and responsibilities, and also official relationships. PROCEDURE Requirements, rights, and duties of employees of the microbiological laboratory are determined in duty regulations. On arrival at work, the employee must be acquainted with corresponding…

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Microbiology

Manufacturing Operations and Controls In Pharma Industry

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Manufacturing Operations and Controls In Pharma Industry All manufacturing operations shall be carried out under the supervision of technical staff approved by the Licensing Authority. Each critical step in the process relating to the selection, weighing, and measuring of raw material addition during various stages shall be performed by trained personnel under the direct personal…

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Uncategorized

Disposal of waste

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Disposal of waste Disposal of waste means eliminating, scraping, recycling, or destroying unwanted materials known as waste that is generated from the manufacturing, packing, and warehousing of industrial pharmaceutical products. Following the correct methods for waste disposal will ensure lesser pollution and hazards to the environment. All the pharmaceutical waste shall be collected initially in…

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Production

Handling of external laboratory activities

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Handling of external laboratory activities To lay down a procedure for qualifying, auditing, sending samples with reference to testing procedures, and obtaining the results for the same. This SOP is applicable to all the external laboratories to which the samples are sent for testing due to the non-availability of in-house facilities/resources. PROCEDURE The external laboratory…

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Quality Control

EXCEL SHEET VALIDATION

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EXCEL SHEET VALIDATION The objective of this procedure is to establish the guideline for the validation of Microsoft Excel spreadsheets use for calculating the product quality parameters. This procedure covers the validation procedure for validation of Microsoft Excel spreadsheets use for calculating the product quality parameters in QA. Procedure Spreadsheets used for simple calculations (e.g:…

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Quality Control

CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING

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CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING The objective of this procedure is to establish the guideline for the calibration of dies required for blend sampling. This SOP is applicable to dies required for a sampling of the blend for validation batches manufactured in the Pharma Industry. Procedure Take a die to be calibrated for…

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Quality Assurance

HANDLING COUNTERFEIT/FALSIFIED MATERIALS

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HANDLING COUNTERFEIT/FALSIFIED MATERIALS To lay down a standard procedure that describes handling counterfeit/falsified materials. Applicable for the procedure of handling counterfeit/falsified materials. PROCEDURE The received material should undergo incoming inspection. If the incoming inspection results of the materials are unsatisfactory, the QA department initiates the investigation of the case. The Authorized person prepares a report…

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Production