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From unraveling the mysteries of drug development to decoding the complexities of regulatory landscapes, Pharma Guide is your indispensable guide through the ever-evolving world of pharmaceuticals. Our meticulously curated content ensures that you’re always one step ahead, empowered with the knowledge and foresight to drive innovation and excellence in healthcare.

Join us on this exhilarating journey as we redefine the boundaries of possibility in pharmaceuticals. Welcome to Pharma Guide – where visionaries thrive, and the future of healthcare unfolds!

Dissolution Testing in Pharmaceuticals (USP <711>)

What is Dissolution Testing? Dissolution testing measures how quickly and completely a drug dissolves in a particular solvent. The United States Pharmacopeia (USP) standard for dissolution testing, known as USP <711>, provides guidelines to ensure consistency and quality in drug release. This test is essential in evaluating how a drug will perform in the body […]

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ICH Guideline

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 […]

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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 […]

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Enhancing 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 […]

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Quality 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 […]

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Packaging Materials

Sampling, 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:

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Microbiology

Guidelines

Dissolution Testing in Pharmaceuticals (USP <711>)

What is Dissolution Testing? Dissolution testing measures how quickly and completely a drug dissolves in a particular solvent. The United States Pharmacopeia (USP) standard for dissolution testing, known as USP <711>, provides guidelines to ensure consistency and quality in drug release. This test is essential in evaluating how a drug will perform in the body […]

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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 […]

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ICH 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 […]

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Nigeria’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 – 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 […]

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Method 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. […]

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Validation

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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