Pharmaceutica Analytica Acta

Therapeutic Drugs and the use of the Hazard Analysis and Critical Control Point (HACCP) Method

Lipert Enumi^* Department of Chemistry, University of Cambridge, Cambridge, UK
^*Correspondence: Lipert Enumi, Department of Chemistry, University of Cambridge, Cambridge, UK, Email:

Received: 03-Apr-2023, Manuscript No. PAA-23-21176; Editor assigned: 07-Apr-2023, Pre QC No. PAA-23-21176(PQ); Reviewed: 21-Apr-2023, QC No. PAA-23-21176; Revised: 28-Apr-2023, Manuscript No. PAA-23-21176(R); Published: 04-May-2023, DOI: 10.35248/2153-2435.23.14.723

Description

The Hazard Analysis and Critical Control Point (HACCP) approach has long been regarded as a food safety administration system. It seeks to avoid known risks and lessen the likelihood that they will materialise at specific points in the food chain. The use of identical techniques is spreading to a variety of different industries, including the chemical, automotive, and aviation sectors. While acknowledging that the specifics of its use could differ based on the circumstances, the general advice on using the HACCP system to assure the quality of pharmaceuticals is provided. On the key risks, it doesn't give specific information. By validating crucial procedures and operations used in the production of final pharmaceutical goods in accordance with Good Manufacturing Practises (GMP), risks that affect integrity are somewhat mitigated. While these factors are covered by HACCP, GMP does not address the safety of manufacturing workers. Procedures, such as GMP, deal with operational issues and form the cornerstone of HACCP. A structured approach to identifying, evaluating, and controlling risk factors is known as HACCP. Biological, chemical, or physical agents or processes that are substantially expected to result in illness or harm if not regulated are referred to as such risks.

Manufacturing some antibiotics, hormones, cytotoxic agents, or other highly active medicines is one example of a hazard unit operation. Other highly active pharmaceuticals may also be manufactured, along with hazard unit processes like fluid-bed drying and granulation. Other potential risks include those associated with the use of flammable solvents (solutions) and specific laboratory procedures. Additionally, HACCP will expand on this idea by assessing the essential quality factors, risks to worker safety, and risks to the environment from pollution that are specifically tied to the process in distributed systems.

Validating crucial procedures and changes to the manufacturing process that can have an impact on the end product's quality are both required by GMP for pharmaceutical items. The majority of production procedures, according to experience, contain steps that are "critical" in terms of variances in the quality of the finished product. Since HACCP takes a more comprehensive approach, it should not be mistaken with validation. This makes it easier to choose the topics that validation should focus on. It is systematic and science-based, identifies particular risks and ways to mitigate them, as well as offering details on labour security and safeguarding the environment. HACCP is a tool for identifying risks and establishing preventative control systems as opposed to corrective action based on end-product testing. All HACCP systems may adapt to changes, such as improvements in processing methods, equipment design, or technological advancements. HACCP should not take the place of GMP, although its implementation could be seen as a precursor to GMP. Compliance with GMP, drug regulatory operations, and inspections offer solid confidence that hazards are mostly under control in nations where proper regulations are present and implemented. However, the creation of subpar pharmaceuticals could put patients at danger in nations where control is less effective.

The assessment of individual risks associated with particular products and starting materials as well as the recognition of hazards at specific stages of production or distribution should allow regulatory organisations to strengthen the regulation of drugs while remaining within the limitations of the resources that are at their removal. The current suggestions are meant to assist businesses in developing and putting into practise effective HACCP plans that address activities including product development, sourcing raw materials, manufacturing, covering, evaluation, and transportation.