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Calibration of UV Spectrophotometer

Calibration, GLP, QC Sop, Quality Control, SOPs Control of Absorbance, Control of Wavelength, Cuvette Qualification, Limit of Stray Light, Linearity Study, Match Pairing of Cells, Resolution (2 nd Derivative test), Resolution Power, SOP for UV Calibration3 Comments on 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

cGMP, Doc, Maintenance Sops, Microbiology, Production, Production Sop, SOPs Cleaning of Equipment, Cleaning of Utility, Cleaning procesure of Equipment, Sanitization of Equipment, SOP cleaning and Sanitization, Utility and Equipment7 Comments on 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.

cGMP, Doc, GLP, Quality Control Function of QC, Function of QC in pharmaceuticlas, QC daily activity, Quality Control Activities, Quality Control Department, Reporting system in QC, Role and Responsibility of QC4 Comments on 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

cGMP, GLP, QC Sop, Quality Control GLP, GLP in QC, Good Laboratory Practices, Good Workbench Practices6 Comments on 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

cGMP, QA Sop IPQA, Lab QA, QA Department, QA Documentation, QA Functions, Quality Assurance, Quality Assurance in Pharma, Responsibilities of QA, Role of QA3 Comments on 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

cGMP, Doc, GLP Burette Cleaning, Glassware, Glassware Cleaning, Good Laboratory Practices, Laboratory Glassware, Pipette Cleaning, Teepol, Volumetric Flask Cleaning1 Comment on 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

cGMP, Doc, Quality Control Analysis of Drug Product, Finished Product, GLP, Good Laboratory Practices, Handling of In-process Sample, Handling of RM, Laboratory Management, Raw Material Sample Analysis1 Comment on 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

cGMP, Doc, Protocol, Validation Cleaning Validation, Cleaning Validation By TOC, CV by HPLC, Do's and Don'ts in Cleaning Validation, Myth and Facts of Cleaning Validation, Validation Protocol2 Comments on 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

cGMP, Doc, Validation Cleaning Validation, CV, CV Protocol, LDD, MACO, MACO Calculation, Validation Master Plan, VMP2 Comments on 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

Calibration, cGMP, HPLC, QC Sop, Quality Control, SOPs Calibration, Calibration of HPLC system, Flow rate, HPLC, HPLC Calibration, Pump CalibrationLeave a Comment on 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

Calibration, cGMP, HPLC, Quality Control, SOPs Calibration, Calibration of HPLC system, Flow rate, HPLC, HPLC Calibration, Pump Calibration1 Comment on 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)

Calibration, cGMP, GLP, HPLC, QC Sop, Quality Control, SOPs Column oven and sample cooler, Drift & Noise, flow rate accuracy, gradient flow measurement, HPLC Pump Calibration, Pressure Test8 Comments on 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. […]

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SOP for material handling and movement (Procedure/Flow Chart)

March 11, 2020 March 6, 2020 pharmabeginers cGMP, Production, Production Sop, Stores Sops material movement procedure, material movement process, material movement sop, Material Transfer1 Comment on SOP for material handling and movement (Procedure/Flow Chart)

Standard Operating procedure (SOP) for material movement in pharmaceutical manufacturing premises form dispensing to the final product. whether material movement from one department to another or within the department. SOP for Material Movement In Manufacturing Premises 1.0      PURPOSE: The purpose of this SOP is to lay down the procedure for material movement procedures […]

Out of Specification (OOS)- SOP and Formats

March 9, 2020 September 18, 2020 pharmabeginers Checklist / Formats, GLP, Protocol, QA Sop, QC Sop, Quality Control, SOPs Cross-functional investigation, Handling of OOS result, Hypothesis Protocol, OOS Flow Chart, OOS Guideline, OOS Investigation, OOS MHRA SOP, OOS trending12 Comments on Out of Specification (OOS)- SOP and Formats

Standard Operating Procedure (OOS) for the handling of Out of Specification Test Results, This SOP is designed based upon MHRA and WHO guideline for Handling of Out of Specification (OOS) results. In the SOP, Detailed procedure provided for the handling of out of specification (OOS) test results, preliminary investigation, Phase I, Phase II and Phase […]

Calibration of Gas Chromatography (GC)

March 7, 2020 March 3, 2020 pharmabeginers Calibration, Checklist / Formats, GC, GLP, Protocol FID Calibration, GC Head Space Calibration2 Comments on 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

March 4, 2020 February 14, 2020 pharmabeginers Calibration, GLP, QC Sop, Quality Control, SOPs, Validation Installation Qualification (IQ), Instrument Requalification SOP, Interim Qualification Instrument, Operational Qualification (OQ), Performance Qualification (PQ), Qualification SOP3 Comments on 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

March 2, 2020 May 13, 2021 pharmabeginers Audit, cGMP, Checklist, Checklist / Formats, GLP, QC Sop, SOPs Handling of OOT, OOT SOP, Out of Trend1 Comment on 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

February 29, 2020 February 11, 2020 pharmabeginers cGMP, Checklist, QC Sop, Quality Control, SOPs, Stores Sops Procedure for Raw Material Sampling, Sampling of Hormone raw materials, Sampling of Psychotropic Raw Materials, sampling of Raw Materials for Retest4 Comments on 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

February 26, 2020 February 7, 2020 pharmabeginers cGMP, Production, Production Sop, SOPs, Stores Sops API Dispensing, Excipient Dispensing, RM Dispensing, Solvent Dispensing1 Comment on 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

February 22, 2020 February 6, 2020 pharmabeginers cGMP, GLP, QC Sop, SOPs, Validation Calibration Standard, Impurity Standard, USP Reference Standard, Working Standard Management, Working standard solvent2 Comments on 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)

February 19, 2020 February 3, 2020 pharmabeginers Audit, cGMP, Checklist / Formats, GLP, Quality Control, SOPs Data Archival, Data Bachup, Data soft copy, HPLC Data, Laboratory Data4 Comments on 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

February 15, 2020 February 3, 2020 pharmabeginers Audit, cGMP, Checklist / Formats, GLP, QA Sop, SOPs Handling Incident SOP, Lab Event, Lab Incident, Laboratory Observation4 Comments on 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

February 12, 2020 February 12, 2020 pharmabeginers Audit, Checklist, Checklist / Formats, Quality Control, SOPs Analysis Report Review, Analytical Report Review, Data Review Check points, Micro Data Review, Microbiology Data, QC Data Review, Raw Data Review, Review Checklist1 Comment on 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

February 9, 2020 February 8, 2020 pharmabeginers cGMP, Production, SOPs, Stores Sops Dispensing of material, Packing material Issuance, Primary Packing Material, Stores SOP, Warehouse SOPLeave a Comment on 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 […]

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SOP for material handling and movement (Procedure/Flow Chart)

March 11, 2020 March 6, 2020 pharmabeginers cGMP, Production, Production Sop, Stores Sops material movement procedure, material movement process, material movement sop, Material Transfer1 Comment on SOP for material handling and movement (Procedure/Flow Chart)

Standard Operating procedure (SOP) for material movement in pharmaceutical manufacturing premises form dispensing to the final product. whether material movement from one department to another or within the department. SOP for Material Movement In Manufacturing Premises 1.0      PURPOSE: The purpose of this SOP is to lay down the procedure for material movement procedures […]

Out of Specification (OOS)- SOP and Formats

March 9, 2020 September 18, 2020 pharmabeginers Checklist / Formats, GLP, Protocol, QA Sop, QC Sop, Quality Control, SOPs Cross-functional investigation, Handling of OOS result, Hypothesis Protocol, OOS Flow Chart, OOS Guideline, OOS Investigation, OOS MHRA SOP, OOS trending12 Comments on Out of Specification (OOS)- SOP and Formats

Standard Operating Procedure (OOS) for the handling of Out of Specification Test Results, This SOP is designed based upon MHRA and WHO guideline for Handling of Out of Specification (OOS) results. In the SOP, Detailed procedure provided for the handling of out of specification (OOS) test results, preliminary investigation, Phase I, Phase II and Phase […]

Calibration of Gas Chromatography (GC)

March 7, 2020 March 3, 2020 pharmabeginers Calibration, Checklist / Formats, GC, GLP, Protocol FID Calibration, GC Head Space Calibration2 Comments on 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

March 4, 2020 February 14, 2020 pharmabeginers Calibration, GLP, QC Sop, Quality Control, SOPs, Validation Installation Qualification (IQ), Instrument Requalification SOP, Interim Qualification Instrument, Operational Qualification (OQ), Performance Qualification (PQ), Qualification SOP3 Comments on 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

March 2, 2020 May 13, 2021 pharmabeginers Audit, cGMP, Checklist, Checklist / Formats, GLP, QC Sop, SOPs Handling of OOT, OOT SOP, Out of Trend1 Comment on 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

February 29, 2020 February 11, 2020 pharmabeginers cGMP, Checklist, QC Sop, Quality Control, SOPs, Stores Sops Procedure for Raw Material Sampling, Sampling of Hormone raw materials, Sampling of Psychotropic Raw Materials, sampling of Raw Materials for Retest4 Comments on 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

February 26, 2020 February 7, 2020 pharmabeginers cGMP, Production, Production Sop, SOPs, Stores Sops API Dispensing, Excipient Dispensing, RM Dispensing, Solvent Dispensing1 Comment on 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

February 22, 2020 February 6, 2020 pharmabeginers cGMP, GLP, QC Sop, SOPs, Validation Calibration Standard, Impurity Standard, USP Reference Standard, Working Standard Management, Working standard solvent2 Comments on 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)

February 19, 2020 February 3, 2020 pharmabeginers Audit, cGMP, Checklist / Formats, GLP, Quality Control, SOPs Data Archival, Data Bachup, Data soft copy, HPLC Data, Laboratory Data4 Comments on 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

February 15, 2020 February 3, 2020 pharmabeginers Audit, cGMP, Checklist / Formats, GLP, QA Sop, SOPs Handling Incident SOP, Lab Event, Lab Incident, Laboratory Observation4 Comments on 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

February 12, 2020 February 12, 2020 pharmabeginers Audit, Checklist, Checklist / Formats, Quality Control, SOPs Analysis Report Review, Analytical Report Review, Data Review Check points, Micro Data Review, Microbiology Data, QC Data Review, Raw Data Review, Review Checklist1 Comment on 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

February 9, 2020 February 8, 2020 pharmabeginers cGMP, Production, SOPs, Stores Sops Dispensing of material, Packing material Issuance, Primary Packing Material, Stores SOP, Warehouse SOPLeave a Comment on 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 […]

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About the author

Ms. Janki Singh is professional pharmaceuticals blogger, Founder and Author of Pharma Beginners. She has rich experience in pharmaceutical field. Email: [email protected]

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