FDA Form 483 | Warning Letters: How to Handle, Form, Example

FDA Form 483 | Warning Letters

Understand and Differentiate them FDA Form 483 and Warning Letters: FDA Form 483 is like a detailed report card that talks about what people saw when they visited the manufacturing site. These people work for the FDA, and they write down everything they notice in a special order based on how important it is. Each … Read more

FIFO, FEFO and LIFO Explanation and Guidelines

FIFO, FEFO, and LIFO are three different methods used in inventory management, warehouse management, and Pharmacy management to determine the order in which items are sold or used. Let’s understand the difference between FIFO, FEFO, and LIFO. What is FIFO FIFO Principle stands for “First In, First Out,” meaning that the first item that was … Read more

Pharmaceutical Quality System (PQS), ICH Q10 Guidelines

ICH Q10 guidelines basically mention the effective Pharmaceutical quality system (PQS). the pharmaceutical quality system is based on the ISO quality system including good manufacturing practice (GMP) regulations. Relationship Between ICH Q8, ICH Q9 and ICH Q10 Before the ICH Q10, ICH Q8 (Pharmaceutical development), and ICH Q9 (Quality risk management) were implemented throughout the … Read more

Nonconformity During Audit and its types with Examples

Nonconformity finding in pharmaceuticals during Audit is a very crucial stage, where finding non-conformity becomes a hurdle for the organization. Nonconformity may be major or minor types it depends on what type of process is affecting at what level. What is Nonconformity As per ISO 19011 “Nonconformity” means non-fulfillment of a requirement, against ISO 9001 … Read more

Change Management System in Pharmaceuticals

Change is driven by innovation, continuous improvement, process performance and product quality monitoring, and CAPA. A firm must have an effective change management system in place in order to effectively review, authorize, and execute these changes. The complexity of change management processes before the original regulatory submission and after submission, where revisions to the regulatory … Read more

Complete Overview of ISO CleanRoom Classification and Risk Assessment

ISO CleanRoom Classification is done to define the limit of particles as per the standardized or predetermined criteria. A cleanroom is one where the viable count and particle count are kept within predetermined and standardized ranges. These rooms must always be kept at the specified level of cleanliness, as their name suggests, and cleaning is … Read more

Difference Between Classified and Non-Classified Areas in Pharmaceuticals

In Pharmaceuticals it is very important to maintain the area as per the products or requirements of GMP. so what if the area where the product is not manufactured? So Based on activity Pharmaceutical industries divided areas into classified and non-classified areas/ Unclassified. The few concepts while Understanding the basic difference between Classified and Non-classified … Read more

Good Laboratory Practice (GLP) in Pharmaceutical

Good Laboratory Practice

Good Laboratory Practice (GLP) is a set of guidelines that helps ensure the quality and reliability of pharmaceutical laboratory data. These GLP guidelines are important because they help to prevent errors and they also ensure that data collected during laboratory testing is accurate and consistent. Understanding GLP guidelines in Pharmaceuticals: Good Laboratory Practice (GLP) guidelines … Read more

What is GMP ­­­| cGMP | GMP Principle


Good manufacturing practice and current good manufacturing practice are both terms correlated with each other. Both GMP and cGMP same purpose and functionality, They work together to achieve the quality, efficacy, and Productivity of a product’s goods. GMP and cGMP: GMP stands for good manufacturing practice, while cGMP stands for current good manufacturing practice. What … Read more

ICH Guidelines in Pharmaceutical (updated)

ICH Guidelines in Pharmaceutical

The world is evolving rapidly, with new diseases and disorders emerging, leading to a higher demand for novel discoveries, including new drug findings. There is consistently high demand for aligning medicinal products to uphold and ensure quality, safety, and efficacy standards for each product. The ICH Guidelines for pharmaceuticals play a significant role in ensuring … Read more

Handling of Laboratory Incident in Pharma

laboratory incident

Laboratory Incident Definition: Any unintentional or unexpected event occurring during, discovered within, or arising after analysis that may adversely impact the quality of data and the resulting outcomes. Types of Common Laboratory Incidents: Below are the different common types of lab incidents in the pharmaceutical field that often occur. Type of Lab incident: Laboratory incidents … Read more

Accelerated stability testing (study) Important Questions

Accelerated stability testing (study) Important Questions

Interview questions regarding accelerated stability testing/studies are explained following the ICH (Q1A, R2, and Q1B step 5) and FDA guidance. Conducting stability studies is important to ensure the quality, safety, and efficacy of drug products throughout their lifecycle, which is a prerequisite for accepting and approving any pharmaceutical product. These accelerated stability studies must be … Read more

ALCOA to ALCOA Plus and Data integrity


Data integrity is a key approach in the pharmaceutical quality control system. ALCOA stands for (Attributable, Legible, Contemporaneous, Original, and Accurate). It was introduced in the 1990s to ensure the framework for data integrity and good documentation practice (GDP). Then further introduced another term called ALCOA+. ALCO+ stands for (Complete, Consistent, Enduring, and Available) currently used by the … Read more