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 […]
Good Laboratory Practices for Workbench
The Quality Control Laboratory in the Pharmaceutical plants plays the critical role to maintain, monitor and consistent product of Pharmaceutical products. In the laboratory from starting material to finished products being tested at the different manufacturing stages. Good Laboratory Practices assist to perform the timely and accurate analytical results. In the day to day activities […]
Quality Assurance Department Functions in Pharmaceuticals
Quality Assurance Department Functions in Pharmaceuticals : Quality Assurance Department shall function for assuring the quality of all the Products manufactured, at every stage of manufacturing / processing of Drug Products. This shall be achieved by performing the functions of monitoring as per the laid systems for the following areas which is not limited to […]
Procedure for Laboratory Glassware Cleaning
Cleaning of laboratory glassware is the key for success of an analysis in the Pharmaceutical Quality Control Laboratory. Even the maximum cautiously performed laboratory analysis can produced erroneous/wrong results if uncleaned glassware is being used during the analysis. If the glassware that is used for measuring solvent / sample solution or standard solutions is contaminated […]
Quality Control Samples
This article is to describe the process and requirements regarding Sample Management in Quality Control Laboratory , including the receipt, handling, controls, maintenance, distribution for testing, and destruction. The implementation of this procedure provides documented records of the chain of custody for the test samples to ensure their accountability and tractability. This article (Laboratory Sample […]
Cleaning Validation Protocol -CV
A cleaning validation protocol shall be developed for the ‘worst case’ product selected for the cleaning validation program. Following information (but not limited to) the following included in the cleaning validation protocol. Numbering of the Cleaning Validation protocol shall be done through of respective SOP of Cleaning Validation Protocol Numbering. Cleaning Validation Protocol Format 1.0 […]
Cleaning Validation master plan (CVMP)-New Approach
Introduction: The cleaning validation Master Plan will function as an umbrella guidance document for all the cleaning validation protocols, programs, and procedures adopted to ensure that all the equipment utilized for the manufacturing of tablets and hard gelatin capsules dosage form is cleaned up at an acceptable level. The Pharmaceuticals manufacturing entities engaged in the […]
HPLC Calibration -A complete Guide -Part 3 of 3
A Complete Guide on HPLC Calibration – Part 3 of 3 (Continued…) In the HPLC Calibration – A complete guide article series, we have discussed about Monthly & Quarterly Calibration parameters, rest of the parameters are described below, in the end of the article all the relevant links has mentioned, in this article there are […]
HPLC Calibration- A complete Guide – Part 2 of 3
Continued from …. A Complete Guide on HPLC Calibration -Part 1 of 3 Part 2 – HPLC Calibration on different Parameter starts from Energy check and completed on wavelength accuracy of Detector In the previous article on HPLC Calibration we have covered following parameters. Pressure Test. Drift and Noise Column oven and sample cooler Pump […]
HPLC System Calibration- A Complete Guide (Part -1)
HPLC System Calibration is the most critical activity in the laboratory, HPLC System is the most sophisticated instrument in the Pharmaceutical Laboratory. Calibration of an instrument is the demonstration that the instrument or device produces results within specified limits by comparison with those produced by reference or traceable standard over an appropriate range of measurement. […]
Calibration of Gas Chromatography (GC)
Standard Operating Procedure (SOP) for Calibration of Gas Chromatography (GC), parameters are Carrier Gas flow Accuracy, Calibration of Flame Ionization Detector (FID) by linearity Measurement, Calibration of Auto-injector by linearity measurement, Calibration for Column Oven temperature measurement, etc. SOP / Protocol for GC Calibration GC Calibration Procedure: At the time of calibration enter the details […]
SOP for Laboratory Instrument Qualification
Standard Operating Procedure (SOP) for Laboratory Instrument Qualification including User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Interim Qualification of Legacy Systems in Quality Control Laboratory. Procedure for Laboratory Instrument Qualification 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for […]
Handling of Out of Trend (OOT) Analytical Test Results
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control. In case of stability out of trend (OOT) results describes as “A results that are within the specification but do not follow the trend, with respect to previous station […]
SOP for Sampling of Raw Material
Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good Manufacturing Practices Guideline). Raw Material sampling is the process of abstraction of a representative portion of material or a group of units from a larger quantity of material or collection of units. Procedure for Raw […]
SOP for Dispensing of Raw Material
Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical drug products. 1.0 PURPOSE: The purpose of this SOP is to define the procedure for dispensing of Raw Materials. 2.0 SCOPE: This procedure is applicable for dispensing of […]
SOP for Working/Reference Standard Qualification
Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard Solvents. SOP for Laboratory Standard Management 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for qualification, handling, storage and usage of reference standards (RS), calibration standards, impurity standards (IMS), […]
SOP for Electronic Data Management (Laboratory)
Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control laboratory. SOP for Electronic Data Management (Laboratory) PURPOSE The purpose of this Standard Operating Procedure (SOP) is; To provide the procedures for Backup, Restoration, Archival and Retrieval of electronic data generated by Stand Alone/Server based […]
SOP For Handling of Laboratory Incident
SOP for handling and reporting of Laboratory Incident (Lab Event ) occurs in the Quality Control like be-Bracketing standard failure, Improper peak shape, Extraneous peak, baseline disturbance, peak elution pattern change, Data missing, wrong standard/sample weight taken, wrong standard/sample preparation, wrong wavelength selection, wrong analytical column selection, etc. SOP for Handling and Reporting of Laboratory […]
SOP for Review of Analytical Report and Raw Data
Standard Operating Procedure (SOP) for Review of Analytical Report and Raw Data. Analytical raw data is data generated during sample analysis and includes traceability of equipment and reagents used for analysis e.g. name of the material, instrument ID, template, chromatograms (Electronic and hard copy), the potency of reference standard / working standard /reagent, calculations, results, […]
SOP for Issuance of Packing Material
Standard Operating Procedure for Issuance / Dispensing of Packaging Material (Packing Materials) like Corrugated box, Primary Packaging Material (PPM), Secondary Packing Material, Aluminum Foils, BOPP tape, PVC Foils, etc. which is required to pack the drug product. Procedure for Packing Material Dispensing / Issuance 1.0 PURPOSE: The purpose of this SOP is to […]
Operation and Calibration of pH Meter
Standard Operating Procedure (SOP) for Operation, standardization, calibration, and maintenance of pH meter including pH meter electrode care. SOP for Operation and Calibration of pH Meter 1.0 PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of operation, standardization, and maintenance of pH meter. 2.0 SCOPE: […]
SOP for Handling of Laboratory Reagents
Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory Reagents 1.0 Purpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. […]
Calibration of Gas Chromatography (GC)
Standard Operating Procedure (SOP) for Calibration of Gas Chromatography (GC), parameters are Carrier Gas flow Accuracy, Calibration of Flame Ionization Detector (FID) by linearity Measurement, Calibration of Auto-injector by linearity measurement, Calibration for Column Oven temperature measurement, etc. SOP / Protocol for GC Calibration GC Calibration Procedure: At the time of calibration enter the details […]
SOP for Laboratory Instrument Qualification
Standard Operating Procedure (SOP) for Laboratory Instrument Qualification including User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Interim Qualification of Legacy Systems in Quality Control Laboratory. Procedure for Laboratory Instrument Qualification 1.0 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for […]
Handling of Out of Trend (OOT) Analytical Test Results
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control. In case of stability out of trend (OOT) results describes as “A results that are within the specification but do not follow the trend, with respect to previous station […]
SOP for Sampling of Raw Material
Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good Manufacturing Practices Guideline). Raw Material sampling is the process of abstraction of a representative portion of material or a group of units from a larger quantity of material or collection of units. Procedure for Raw […]
SOP for Dispensing of Raw Material
Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing of pharmaceutical drug products. 1.0 PURPOSE: The purpose of this SOP is to define the procedure for dispensing of Raw Materials. 2.0 SCOPE: This procedure is applicable for dispensing of […]
SOP for Working/Reference Standard Qualification
Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard Solvents. SOP for Laboratory Standard Management 1.0 PURPOSE: The purpose of this SOP is to describe the procedure for qualification, handling, storage and usage of reference standards (RS), calibration standards, impurity standards (IMS), […]
SOP for Electronic Data Management (Laboratory)
Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control laboratory. SOP for Electronic Data Management (Laboratory) PURPOSE The purpose of this Standard Operating Procedure (SOP) is; To provide the procedures for Backup, Restoration, Archival and Retrieval of electronic data generated by Stand Alone/Server based […]
SOP For Handling of Laboratory Incident
SOP for handling and reporting of Laboratory Incident (Lab Event ) occurs in the Quality Control like be-Bracketing standard failure, Improper peak shape, Extraneous peak, baseline disturbance, peak elution pattern change, Data missing, wrong standard/sample weight taken, wrong standard/sample preparation, wrong wavelength selection, wrong analytical column selection, etc. SOP for Handling and Reporting of Laboratory […]
SOP for Review of Analytical Report and Raw Data
Standard Operating Procedure (SOP) for Review of Analytical Report and Raw Data. Analytical raw data is data generated during sample analysis and includes traceability of equipment and reagents used for analysis e.g. name of the material, instrument ID, template, chromatograms (Electronic and hard copy), the potency of reference standard / working standard /reagent, calculations, results, […]
SOP for Issuance of Packing Material
Standard Operating Procedure for Issuance / Dispensing of Packaging Material (Packing Materials) like Corrugated box, Primary Packaging Material (PPM), Secondary Packing Material, Aluminum Foils, BOPP tape, PVC Foils, etc. which is required to pack the drug product. Procedure for Packing Material Dispensing / Issuance 1.0 PURPOSE: The purpose of this SOP is to […]
Operation and Calibration of pH Meter
Standard Operating Procedure (SOP) for Operation, standardization, calibration, and maintenance of pH meter including pH meter electrode care. SOP for Operation and Calibration of pH Meter 1.0 PURPOSE: The purpose of this SOP (Standard Operating Procedure) is to describe the procedure of operation, standardization, and maintenance of pH meter. 2.0 SCOPE: […]
SOP for Handling of Laboratory Reagents
Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC. Receipt, Storage, and Handling of Laboratory Reagents 1.0 Purpose : The purpose of this SOP ( Standard Operating Procedure) is to describe the procedure for the receipt, storage, and handling of laboratory reagents. […]
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