Industrial Pharmacy
Stabilizing a Pharmaceutical Formulation through Packaging
In pharmaceutical development, formulation stability is often discussed only in terms of excipient selection and process optimization. However, in real-world product development, stability is achieved through an integrated approach involving formulation, process, and packaging together. Packaging is not merely a container. It is a functional component of the drug product ... Read More
End-to-End DoE Implementation Framework
1. Define the ObjectiveEvery DoE must start with a clearly defined objective. This answers the fundamental question: Why are we doing this experiment?Typical objectives include identifying critical factors, optimizing a formulation or process, or resolving a specific quality or performance issue. A weak objective leads to weak learning. 2. Identify ... Read More
Developing an Effective Control Strategy within a QbD Framework
Quality by Design is not about documentation. It is about understanding how materials and processes influence product quality and patient safety. The pharmaceutical control strategy develops step by step, as outlined below: I. Identification of Critical Material Attributes (CMAs) CMAs are physical or functional properties of raw materials that can ... Read More
Types of Variation Filings in UK and Europe
In pharmaceutical regulatory affairs, product life does not end with approval. Every post-approval change must be scientifically justified and filed through a defined regulatory pathway. These post-approval submissions are known as Variation Filings, and both the European Union and the United Kingdom follow structured classification systems to manage them. In ... Read More
ICH Q9 (Quality Risk Management) | Moving from Compliance to Scientific Decision-Making
In pharmaceutical development and manufacturing, not every issue carries the same level of risk. ICH Q9 was introduced to bring structure, science, and proportionality into how quality decisions are made. At its core, ICH Q9 defines QRM as a systematic process for the assessment, control, communication, and review of risks ... Read More
Global Product Development | Key Steps and Common Mistakes
1. Product Identification & Target Market Definition Steps: Common Mistakes: 2. API and Excipient Selection Steps: Common Mistakes: 3. Formulation Development Steps: Common Mistakes: 4. Analytical Development Steps: Common Mistakes: 5. Stability and Compatibility Studies Steps: Common Mistakes: 6. Process Optimization and Scale-Up Steps: Common Mistakes: 7. Bioequivalence and Clinical ... Read More
Multiple Peak Plasma Concentrations (Cmax) of Drugs
There are several potential reasons for multiple peak plasma concentrations. One of which is gut-liver (enterohepatic) recycling (EHR) of drugs. Why is this EHR important for our health? It explains why our gut health (i.e. gut bacteria) can affect drug handling in our body and its treatment (therapeutic) effect. Read ... Read More
Cleaning Validation | FDA vs EMA
I have reviewed 50+ cleaning validation protocols this year. And here is what still surprises me: Most companies treat FDA and EMA requirements as identical twins. They are not. The reality is: Last year, a client passed their FDA pre-approval inspection comfortably. Same facility. Same equipment. Same cleaning procedures. Three ... Read More
Why is Testing into Compliance Prohibited?
“Testing into Compliance” — A Red Flag for FDA Inspectors In pharmaceutical manufacturing, data integrity is non-negotiable. Yet some companies still engage in the risky practice of testing into compliance — retesting until a passing result is found, while ignoring or discarding out-of-specification (OOS) results without proper scientific justification. This ... Read More
Understanding the Inactive Ingredient Guide (IIG)
The Inactive Ingredient Guide (IIG) is a regulatory database published and maintained by the United States Food and Drug Administration (USFDA). It serves as a critical reference for pharmaceutical scientists, formulation developers, and regulatory affairs professionals engaged in the development and approval of drug products—particularly generic drugs submitted through the ... Read More
Selection of Reference Product Across Different Regulatory Markets
Selecting the appropriate reference product is a key step in generic drug development. It serves as the basis for bioequivalence studies and regulatory submissions. The definition and selection criteria for a reference product vary by region, as outlined below. 1. United States (USFDA) – Reference Listed Drug (RLD) The USFDA ... Read More