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SOP for Reduce Testing
Reduce Testing in Raw Material Standard Operating Procedure (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity of Quality Control for speedy release of RM. 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for reduce testing in analysis of raw materials.. 2.0 […]
SOP for Control Sample Management
Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system in which the product is marketed. It may Starting Material, Packaging Material, Drug Substance or Finished Drug Product which is stored to evaluate the potential risk during self life of the batch. Sample should be […]
Raman Analyzer – Handling Procedure (SOP)
The Development of hand-held Raman Spectrometers has drastically changed the manner of internal control for incoming raw material. Raman has provided advantages over alternative ways in this. It doesn’t need sample pre-treatment or direct contact with the sample, and has the unique capability of having the ability to check a sample directly through a clear wadding like glass or plastic. With the additional benefit of portability, hand-held Raman spectrometers significantly increase potency/productivity by eliminating […]
Hold Time Study of Cleaned Equipment (CEHT)
Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments needs to be established to ensure that it is capable of consistently achieving desired level of cleanliness. To ensure the state of cleaning Hold time Study is required. This validation study to be executed for […]
Internal Audit (Self Inspection) Checklist
Internal Audit (Self Inspection) checklist for various departments of Pharmaceuticals like Quality Control, Quality Assurance, Production, HR and EHS etc. Below Internal Audit (Self Inspection) checklist being used for the assessment of respective departments . these are the minimum requirement for the compliance. It would be the agenda of Internal Audit (Self Inspection) checklist. Copy […]
SOP on Internal Audit and Self Inspection
In the SOP on Internal Audit and Self Inspection, describe the detailed procedure to carryout the the Self inspection and Internal Audit in various department of pharmaceuticals. Audit is a systemic and independent examination to determine the quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are […]
SOP For Operation of Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP)
The SOP for the operation of the Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) to define the comprehensive procedure for handling the waste of pharmaceuticals. Effluent Treatment Plant (ETP) – The mechanism or process used to treat the wastewater prior to release into the environment or its reuse. Sewage Treatment Plant (STP) -It […]
Annual Product Review (APQR / APR / PQR)
Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well as finding out the scope of quality improvement by controlling the critical process parameters (CPP). Visit to copy this SOP APR – Annual Product Review also known as APQR – Annual Product Quality Review and […]
Laminar Air flow (LAF) – Operation, Cleaning and Qualification
LAF : Laminar Air Flow – Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling. The Operation, Cleaning, Maintenance and Qualification of Laminar Air Flow (LAF) shall discussed in below SOP. Laminar Air flow (LAF) – Operation, Cleaning and Qualification […]
Calibration of UV Spectrophotometer
Calibration of UV spectrophotometer (UV-VIS Spectrophotometer) for all parameters as per IP, BP and USP pharmacopoeia like, Internal Calibration, Match pairing of UV cell / cuvette, Control of wavelength, control of Absorbance, Limit of Stray light, Resolution and Resolution Power, Linearity Study and 2nd derivatives. UV Calibration / Calibration of UV Spectrophotometer : Parameters : […]
Cleaning and Sanitization in Pharmaceuticals
Cleaning and sanitization of Utility system and Equipment is crucial to maintain the Quality of the drug product and to avoid the cross contamination also Standard Operating Procedure for Cleaning and Sanitization PURPOSE: The purpose of this Standard Operation Procedure is Defines the requirements Ensure that facility and Equipment Cleaning and Sanitization are managed and […]
Functions and Reporting system of Quality Control Department in Pharmaceuticals.
In Pharmaceutical industries Quality Control (QC) is believe as one of the most vital department.It acts as a barrier between the manufacturing unit and Market to ensure the Quality of the manufactured product. In Quality Control Functions Large numbers of employees are work together in QC department at different grade with a common Aim, which […]
SOP for Reduce Testing
Reduce Testing in Raw Material Standard Operating Procedure (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity of Quality Control for speedy release of RM. 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for reduce testing in analysis of raw materials.. 2.0 […]
SOP for Control Sample Management
Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system in which the product is marketed. It may Starting Material, Packaging Material, Drug Substance or Finished Drug Product which is stored to evaluate the potential risk during self life of the batch. Sample should be […]
Raman Analyzer – Handling Procedure (SOP)
The Development of hand-held Raman Spectrometers has drastically changed the manner of internal control for incoming raw material. Raman has provided advantages over alternative ways in this. It doesn’t need sample pre-treatment or direct contact with the sample, and has the unique capability of having the ability to check a sample directly through a clear wadding like glass or plastic. With the additional benefit of portability, hand-held Raman spectrometers significantly increase potency/productivity by eliminating […]
Hold Time Study of Cleaned Equipment (CEHT)
Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments needs to be established to ensure that it is capable of consistently achieving desired level of cleanliness. To ensure the state of cleaning Hold time Study is required. This validation study to be executed for […]
Internal Audit (Self Inspection) Checklist
Internal Audit (Self Inspection) checklist for various departments of Pharmaceuticals like Quality Control, Quality Assurance, Production, HR and EHS etc. Below Internal Audit (Self Inspection) checklist being used for the assessment of respective departments . these are the minimum requirement for the compliance. It would be the agenda of Internal Audit (Self Inspection) checklist. Copy […]
SOP on Internal Audit and Self Inspection
In the SOP on Internal Audit and Self Inspection, describe the detailed procedure to carryout the the Self inspection and Internal Audit in various department of pharmaceuticals. Audit is a systemic and independent examination to determine the quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are […]
SOP For Operation of Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP)
The SOP for the operation of the Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) to define the comprehensive procedure for handling the waste of pharmaceuticals. Effluent Treatment Plant (ETP) – The mechanism or process used to treat the wastewater prior to release into the environment or its reuse. Sewage Treatment Plant (STP) -It […]
Annual Product Review (APQR / APR / PQR)
Annual Product Review (APR) is the requirement of various regulatory agencies. APR roots the monitoring of product quality as well as finding out the scope of quality improvement by controlling the critical process parameters (CPP). Visit to copy this SOP APR – Annual Product Review also known as APQR – Annual Product Quality Review and […]
Laminar Air flow (LAF) – Operation, Cleaning and Qualification
LAF : Laminar Air Flow – Airflow which is linear and positive up to working surfaces and thus prevents contamination of surrounding viable/ non viable particulate matter in aseptic handling. The Operation, Cleaning, Maintenance and Qualification of Laminar Air Flow (LAF) shall discussed in below SOP. Laminar Air flow (LAF) – Operation, Cleaning and Qualification […]
Calibration of UV Spectrophotometer
Calibration of UV spectrophotometer (UV-VIS Spectrophotometer) for all parameters as per IP, BP and USP pharmacopoeia like, Internal Calibration, Match pairing of UV cell / cuvette, Control of wavelength, control of Absorbance, Limit of Stray light, Resolution and Resolution Power, Linearity Study and 2nd derivatives. UV Calibration / Calibration of UV Spectrophotometer : Parameters : […]
Cleaning and Sanitization in Pharmaceuticals
Cleaning and sanitization of Utility system and Equipment is crucial to maintain the Quality of the drug product and to avoid the cross contamination also Standard Operating Procedure for Cleaning and Sanitization PURPOSE: The purpose of this Standard Operation Procedure is Defines the requirements Ensure that facility and Equipment Cleaning and Sanitization are managed and […]
Functions and Reporting system of Quality Control Department in Pharmaceuticals.
In Pharmaceutical industries Quality Control (QC) is believe as one of the most vital department.It acts as a barrier between the manufacturing unit and Market to ensure the Quality of the manufactured product. In Quality Control Functions Large numbers of employees are work together in QC department at different grade with a common Aim, which […]
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