Quality control and quality assurance are two essential concepts that help ensure the safety and quality of the finished products. While both concepts share the same goal of maintaining high standards, they approach this goal in different ways. Quality control involves inspecting and testing products at various stages of production to ensure that they meet…
IPC are checks that are carried out during manufacturing process running and/or before the manufacturing process is completed. The function of in-process controls is in-process monitoring in order to comply with the specifications. This may include control of equipment and environment too. In-process materials should be tested for identity, strength, quality and purity as appropriate…
OOS and OOT are two common terms in pharmaceutical quality control laboratory. In this article we mention the similarities and differences between Out of Specifications (OOS) and Out of Trend (OOT) Similarities between Out of Specifications (OOS) and Out of Trend (OOT) a. Both OOS and OOT are conducted in the pharmaceutical industry to identify…
A raw material specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. The justification should refer to relevant…
As per ICH Guideline,A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. The justification should refer to…
Data integrity in the analytical laboratories is an area of increasing focus for regulatory authorities such as FDA, EU, TGA etc. Data Integrity The data which is attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). During regulatory inspection/audit analytical laboratories have to provide information about the validation of their methods and…
The mucosal route of drug administration is subdivided into seven membrane surfaces for the purposes of taxonomic distinction of dosage forms by route of administration. These membrane surfaces are characterized as otic, ophthalmic, nasal, oropharyngeal, urethral, vaginal, and rectal. In this article we provides product quality tests that are generally necessary, tests that apply to…
Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boundary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Injections may exist as either immediate- or extended-release dosage forms. Implanted parenteral…
Topically applied drug products fall into two general categories: (1) those applied to achieve local action and (2) those applied to achieve systemic effects after absorption through the skin into the blood circulation. They include, but are not restricted to creams, gels, ointments, pastes, suspensions, lotions, foams, sprays, aerosols, solutions, and transdermal patches. Product Quality…
Oral drug products fall into two main categories: solids and liquids. Solid oral drug products include but are not restricted to capsules, tablets, granules, and powders. Similarly, liquid oral drug products include but are not restricted to solutions, suspensions, and emulsions. Drug Product Quality Test Drug product quality tests for oral drug products fall into…