In pharma, market complaints are a critical part of the Pharmaceutical Quality System (PQS) because they can signal potential risks to patient safety, product quality defects, counterfeit infiltration, or distribution failures. What complaints typically include Common complaint categories are: How…
Corrective and Preventive Action (CAPA) in pharma is the structured system used to eliminate the cause of an existing problem (corrective action) and to prevent potential problems from occurring (preventive action). CAPA is a core element of the Pharmaceutical Quality…
In pharma, an incident is any unplanned event that disrupts normal operations or creates a potential or actual risk to product quality, patient safety, regulatory compliance, data integrity, environment, or worker safety. Incidents can occur in manufacturing, packaging, QC laboratories,…
In pharma, a deviation is any departure from an approved instruction, established procedure, validated process, specification, or expected condition during manufacturing, packaging, testing, storage, or distribution. Deviations matter because they can affect product quality, patient safety, data integrity, and regulatory…
Change Control in pharma is the formal, documented system used to propose, evaluate, approve, implement, and review any change that could impact product quality, patient safety, compliance, or data integrity. It is a core element of the Pharmaceutical Quality System…
Calibration in pharma is the documented process of verifying and adjusting instruments so they measure accurately and consistently within defined limits. It is a fundamental GMP requirement because critical decisions—batch release, process control, environmental monitoring, and safety—depend on reliable measurements.…
Batch release in pharma is the formal, documented decision that confirms a manufactured batch is fit for sale and patient use. It verifies that teams produced, tested, packed, stored, and reviewed the batch in compliance with approved procedures, GMP, and…
A pharma warehouse is a GMP/GDP-controlled storage and distribution area that protects raw materials, packaging materials, intermediates, and finished products so they remain identity-preserved, traceable, and within specification until use or dispatch. Warehousing is critical because poor storage can cause…
Epoxy flooring in pharma is a seamless, non-porous resin floor system used in manufacturing, packaging, QC labs, and warehouses to support GMP cleanliness, durability, and contamination control. Its main value is that it creates a surface that is easy to…
The molybdenum spot test in pharma is a quick, on-the-spot positive material identification (PMI) screening test used mainly to confirm whether stainless-steel items in contact with product/utility are molybdenum-bearing grades (e.g., SS316/316L) rather than molybdenum-free grades (e.g., SS304). This matters…
Calculator validation in pharma ensures that any calculator used for GMP decisions produces accurate, consistent, and traceable results. It applies to calculators used for critical calculations in manufacturing, QC, QA, engineering, and validation—such as assay calculations, dilution factors, yields, label…
A Purified Water (PW) system in pharma is a controlled utility designed to generate, store, and distribute water that meets pharmacopeial requirements for chemical purity and microbiological quality. PW is widely used for non-sterile product manufacturing, equipment cleaning, and as…