The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB 1 to OEB 5-6 degree…
Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be considered by an institution to…
A standard operating procedure generally includes an introduction, background, ownership, instructions, and traceability, all outlined in an agreed-upon format and complete with references, appendixes, and annexures. Although the presentation may differ from the order described here, it must comply with Good Document Practice (GDP). The following standard operating procedure sections are included for completeness; their…
A SOP is a document that provides high-level guidelines for a process. There are different types of SOPs in the pharmaceutical industry. To be most effective, standard operating procedures should be succinct, intuitive, easy to navigate, traceable, and regularly approved. To ensure compliance and traceability to a qualified state are achieved, companies should make approved…
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every department has its SOPs. SOP management refers to the systematic process of creating, implementing, reviewing…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development: Preclinical Development Clinical Development Registration Post-approval Overall, these ICH quality…
Change management is crucial in any Commissioning, Qualification, and Validation (CQV) activity within the pharmaceutical and other regulated industries for several important reasons: Robust change management helps ensure compliance, manage risks, maintain product quality, and facilitate efficient and controlled change implementation. It is an integral part of maintaining the quality, safety and efficacy of pharmaceutical…
An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the world for use without medical…
Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility. CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the lifecycle of the facility or…
Holdtime can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications. 21 CFR 211.111 Time Limitations on Production states: When appropriate, time limits for the completion of each phase of…