Validation is a tool of quality assurance which provides confirmation of the quality in equipment systems, manufacturing process, software and testing methods. If each step of production process is validated we can assure that the final product is of best quality. Different dosage forms have different validation protocols. In this study process validation of Sodium Valproate enteric coated tablets of strength 200mg and 500mg was carried out. A common protocol was prepared for both the strengths and two batches of each were taken. In-process monitoring of all the critical processing steps such as dry mixing, granulation, wet milling, drying, dry milling, lubrication, compression and coating was done for this transferred product to show that the process was under control. LOD of dried, milled and lubricated granules were checked and was found within the limit. Assay after lubrication was within the specified limit, indicating blend uniformity. Physical parameters, dissolution, assay, test for related substance and residual ethanol content were performed and results found within the acceptance criteria. Keywords: Process validation, Tablets, Quality, Protocol, Manufacturing process. INTRODUCTION:1-9 The primary objective of any pharmaceutical plant is to manufacture products of requisite attribute and quality consistently, at the lower possible cost. Although validation studies have been conducted in he pharmaceutical industry for a long time, there is an ever-increasing interest in validation owing to their industry’s greater emphasis in recent years on quality assurance and productivity improvement. Validation is a necessary part of a quality assurance program and is fundamental to an efficient production operation. Process valida... ... middle of paper ... ... study department is responsible for performing stability studies and compilation of the results. Quality Assurance: QA is responsible for review and approval of the process validation protocol and report, as well as for managing validation constraints and deviations. It is within the scope of QA to approve and release of the validation batch for further processing and to manage any failure/ deviation/ out of specifications encountered during the progress of process validation. Engineering: Engineering is responsible to ensure that all the individual utilities and equipments are qualified, calibrated and ready for use. HSE: Health, safety and environment is responsible to ensure that appropriate personnel protective equipment are in place. It is responsible to ensure that adequate safety instructions have been given to the personnel involved in handling the product.
It also assesses these conformity assessment bodies and then accredits them where they are found to meet the internationally specified standard. UKAS works with a variety of government departments to support the principles of good policy by making and efficient delivery. Accreditation ensures that the everyone from specifiers, purchasers, and suppliers to consumer can have confidence in the good quality and in the provision of services throughout the supply chain. UKAS is licensed by British Standards Institution and consult the national accreditation symbols which symbolize Government recognition of the accreditation process. Health and Safety at Work (HSE) Act The Health and Safety Executive (HSE) is the law that provide safety and covers all features and areas of the workplace.
The analysis is therefore one of the most effective methods of ensuring that each drug being prescribed to patients is safe. It also ensures that all drug components are understood in terms of their structure and chemical behavior. This understanding is very important in the manufacture of drugs and other pharmaceutical products.
FTC requires the manufacturer must provide all ingredients, their quantity, and their significant relationship with the health condition. They must scientific proof, reliable evidence to support their claim. The product has to be clinically tested on humans. It has to be undergone through various placebo controlled and experimental group. Finally the data is collected and conclusion is made based on numerous evidence and support. After that the theory has to be reviewed by experts in the same field to be granted as a scientific proof. US food and drug administration board permits some claims on the product label, with some restrictions. There are four general categories of claims made. Firstly, health claims, which have numerous study and evidences to support them. Secondly, Preliminary claims like on phytochemicals, which have some evidences but no proper research ha...
Compliance with all safety regulations of assigned tasks, and ensure a clean and safe working environment with active participation in the health and safety program
The HR Director is responsible for investigating the situation and all parties involved to conclude if malpractice is evident. It is a role of the Human Resources Director to be involved in patient safety, which is dependent upon the actions of the facility’s personnel (Shi, 2010, p. 211). Employee training in maintaining patient safety and training on malpractice avoidance can be incorporated into new hire orientation.
Occupational Safety and Health Administration also known as OSHA is a U.S. regulatory agency that is used to implement the safety of employees, patients and the enviro...
Generic drugs must be equal to the brand-name drug. The FDA requires generic drugs to contain the same active ingredient, the dosage form must be identical, strength must be the same, and route of administration must be the same as the brand-name drug in order to obtain FDA approval (Food and Drug Administration, 2013). The manufacturer must also prove the generic drug delivers the same amount of the active ingredient as the brand-name drug. This bioequivalence assists in drawing the conclusion that the generic and brand-name drug will produce therapeutic results that are very similar (Food and Drug Administration, 2012).
To continue, compounding would be needed if a patient wants to change something about the medicine such as flavor or strength. It is vital that s...
Health and Safety Executives (HSE) is a UK government body that is responsible for enforcing Health and safety at work legislation.
biopharmaceutical industry. Manuscript submitted for publication, Sloan School of Management and the Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts. Retrieved from dspace.mit.edu/bitstream/handle/1721.1/34827/61670866.pdf?sequence=1.
The management should consider these results and make sure that the product should be free of any additives so as to
One of the questions people may ask is does a label indicate the quality of a dietary supplement product. It is difficult to determine the quality of a dietary supplement product from its label but, the degree of quality control depends on the manufacture, the supplier, and others in the production process. In 2007, the FDA issued good manufacturing practices for dietary supplements, also a set of requirements and expectations by which dietary supplements must be manufactured, and prepared and stored to ensure quality. Manufacturers are now expected to guarantee the identity, purity, strength, and composition of their dietary products. For example, the GMP‘s aim to prevent the inclusion of the wrong ingredients, not to mention the addition of too much or too little of a dietary ingredient, increases the possibility of contamination, pesticides, heavy metals such as lead, bacteria, etc., and the improper packaging and labeling of a product. Another question is are dietary supplement standardized? Standardization is a process that manufactures may use to ensure batch to batch consistency of their products. In some cases, standardization involves identifying specific chemicals known as markers that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control. Dietary supplements are not
Mims, E., Tucker, C., Carlson, R., Schneider, R., & Bagby, J. (2009). Quality-monitoring program for bar-code-assisted medication administration. American Journal of Health System Pharmacy, 66, 1125-1131.
Employers negligent in providing health and safety in the work environment could become criminally charged, fined or sent to jail. Providing an unsafe workplace is no longer considered just as morally unjust, but an act of crime. Health and safety in the workplace has become more encompassing and broader, accepting new causes and problems that influence occupational health and safety. Health is no longer just defined as wellness of the physical body, but also wellness of the mind. Mental health is considered an area of workplace safety.
Ensuring the health and safety of employees is of primary importance to the Organization. Organization is committed to maintaining safe facilities, sponsoring appropriate training programs, and providing necessary safety equipment. In addition, Administration and staff shall cooperatively develop appropriate procedures and regulations for ensuring employees' health and safety, with special emphasis on the handling of potentially hazardous equipment or substances and for investigating and reporting any accidents and mishaps. All newly employed staff shall be required to comply with the physical examination. Every employee must provide annually, at a minimum, an updated health history of current health problems.