Q1/Q5C EWG Targeted Revisions of the ICH Stability Guideline SeriesQ10 Pharmaceutical Quality SystemQ11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug SubstancesQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle ManagementQ12 IWG Training on Regulatory and Technical […]
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Validation and Verification of Compendial Procedures: USP <1225>
In the pharmaceutical industry, it is critical to ensure that testing methods are accurate, reliable, and suitable for their intended purpose. USP <1225> and USP <1226> provide guidelines to achieve this by focusing on the validation and verification of analytical procedures. Key Parameters for Validation Below is a table summarizing the parameters required for different […]
Read MoreCTD Modules for the West African Pharmaceutical Market
The West African Health Organization (WAHO) has adopted the Common Technical Document (CTD) format to standardize the registration of pharmaceutical products across the Economic Community of West African States (ECOWAS). This format helps pharmaceutical companies get their products approved more efficiently, ensuring that medicines meet international safety and quality standards. 1. What is the Common […]
Read MoreICH Quality Guidelines
The International Council for Harmonisation (ICH) is a global organization that plays a key role in ensuring that medicines are safe, effective, and high quality. It brings together regulatory authorities and the pharmaceutical industry from different regions to develop guidelines that harmonize the processes of drug development and approval. What Are ICH Guidelines? ICH Guidelines […]
Read MoreNigeria’s Drug and Related Product Labelling Regulations (2021)
The Drug and Related Product Labelling Regulations, 2021, introduced by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), lay down the rules for the labeling of drugs and related products. These regulations aim to ensure that all drug products in Nigeria are labeled clearly, accurately, and in line with safety standards. Here’s […]
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Quality Control
Common Challenges in Pharmaceutical Manufacturing and How to
Different challenges in pharmaceutical manufacturing that manufacturers face during the running of a manufacturing firm and some useful strategies. The pharmaceutical manufacturing process is a highly regulated process that has different challenges related to manufacturing, quality and compliance. A small error can cause a big financial loss as well as to company’s reputation. It requires […]
Read MoreEnhancing Efficiency and Quality: Implementing Lean Manufacturing Principles
Lean manufacturing principles are about reduction of waste and errors in manufacturing process and improvements in quality and customer satisfaction. In pharmaceutical manufacturing product quality, efficiency and regulatory compliance have important roles. To maintain product quality and use manpower efficiently, lean manufacturing principles play an important role. Lean manufacturing principles can help to optimize manufacturing […]
Read MoreQuality Assurance
Preparation of Site Master File – SOP
SOP for Site Master File | Site Master File of Pharma Company | 1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY 4.0 ACCOUNTABILITY 5.0 PROCEDURE 5.1 Prepare Site master file containing specific information about the quality management policies, activities of the site like the production & quality control of the pharmaceutical manufacturing operations carried out at the site […]
Read MorePackaging Materials
Operation of Micrometer Screw Gauge SOP
1.0 OBJECTIVE : 2.0 SCOPE : 3.0 RESPONSIBILITY : 4.0 ACCOUNTABILITY: 5.0 PROCEDURE : 5.1 OPERATION
Read MoreSampling, Testing and Approval/Rejection of Packaging Material –
SOP for Packaging Material Testing | Sampling plan for packaging materials | AQL for packaging material | 1.0 OBJECTIVE : 2.0 SCOPE : 3.0 RESPONSIBILITY : 4.0 ACCOUNTABILITY: 5.0 PROCEDURE : 5.1 Definitions 5.2 Receiving of Goods Receipt Note (GRN): 5.3 Planning for Sampling of Packaging Materials:
Read MoreMicrobiology
Checking personnel hygiene by dab test method-SOP
1.0 OBJECTIVE 2.0 SCOPE 3.0 RESPONSIBILITY 4.0 PROCEDURE :
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Guidelines
CTD Modules for the West African Pharmaceutical Market
The West African Health Organization (WAHO) has adopted the Common Technical Document (CTD) format to standardize the registration of pharmaceutical products across the Economic Community of West African States (ECOWAS). This format helps pharmaceutical companies get their products approved more efficiently, ensuring that medicines meet international safety and quality standards. 1. What is the Common […]
Read MoreICH Quality Guidelines
The International Council for Harmonisation (ICH) is a global organization that plays a key role in ensuring that medicines are safe, effective, and high quality. It brings together regulatory authorities and the pharmaceutical industry from different regions to develop guidelines that harmonize the processes of drug development and approval. What Are ICH Guidelines? ICH Guidelines […]
Read MoreNigeria’s Drug and Related Product Labelling Regulations (2021)
The Drug and Related Product Labelling Regulations, 2021, introduced by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), lay down the rules for the labeling of drugs and related products. These regulations aim to ensure that all drug products in Nigeria are labeled clearly, accurately, and in line with safety standards. Here’s […]
Read MoreQuality Control – Principle, General information
Quality Control in Medicinal Products | Quality Control Principle | Quality Control General Information | Good Quality Control Laboratory Practice | Play Video Inside the Pharmaceutical Quality Control Department: Ensuring Safety and Efficacy Quality Control Principle – Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures […]
Read MoreMethod of Analysis (MOA)
Cartons – Packaging material standard test procedure
Folding cartons are small to medium sized cardboard boxes made from paper board. The paperboard are cellulose derived substrate, with thickness generally greater than 200 mm which are made from virgin and recycled fiber. They are used to package a wide range of products because of the ability to satisfy the function of protecting and utility. […]
Read MoreValidation
Validation Master Plan – SOP
1.0 OBJECTIVE : 2.0 SCOPE : 3.0 RESPONSIBILITY : 4.0 ACCOUNTABILITY: 5.0 PROCEDURE : 6.0 ABBREVIATIONS: Abbreviation Expanded form SOP Standard Operating Procedure Q.A. Quality Assurance QC Quality Control VMP Validation Master Plan i.e. That is HVAC Heating Ventilation and Air Conditioning 7.0 ANNEXURES Annexure No. Title 01 Format for Validation Master Plan
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