A Review on Cleaning Validation-Regulatory Guidelines for The Pharmaceutical Industry

Beula, S. Janet; Suthakaran, R.; Ramulu, Y.; Viswaja, M.; Venkateswaralu, G.

doi:10.52711/2231-5691.2022.00026

Cited by 6 publications

(2 citation statements)

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“…In feed manufacturing, carryover can occur in a single piece of equipment, multiple pieces, or the entire production line [13]. The phenomenon also occurs in the human food and pharmaceutical industries [14,15].…”

Section: Introductionmentioning

confidence: 99%

The Mechanism of Drug Carryover in Feed Manufacturing as a Function of Drug Properties and Equipment Design—A Brief Review

Akoto,

Maier

2023

Agriculture

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This paper thoroughly reviews the mechanism of veterinary drug carryover in feed manufacturing facilities, factors resulting in varying concentrations of drug carryover in processing equipment, the impact of chemical and physical properties of drugs, and the effect of equipment type and design. The Google Scholar database (from 1998 to 2023) was searched with words and phrases such as drug carryover, feed manufacturing, equipment cleaning and validation, food allergen control, sources of drug carryover, and process parameters in drug carryover. Some papers were from the Iowa State University Library database and PubMed. Drug carryover is a function of ingredients, nature of drugs, equipment type, process parameters, and cleaning procedures. The gaps are the lack of commercial feed mills data on the role and interaction of nanomaterials, molasses, equipment type, and process parameters in drug carryover in animal feed. Modification of process parameters, e.g., airflow in bucket elevators and the interaction of feed ingredients, composition, equipment type, and design, need to be investigated in the commercial setting to address drug carryover. Rhetorically, can big data facilitate the standardization of cleaning procedures at feed mills? The findings can result in drug carryover prevention/control in animal feed and animal-based human food.

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Section: Introductionmentioning

confidence: 99%

The Mechanism of Drug Carryover in Feed Manufacturing as a Function of Drug Properties and Equipment Design—A Brief Review

Akoto,

Maier

2023

Agriculture

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“…A good manufacturing practice (GMP) is essential to prevent contamination of pharmaceutical products and starting materials. It has been demonstrated that pharmaceutical products are susceptible to contamination from a variety of contaminants, including microorganisms, past products (including active pharmaceutical ingredients and excipients), residues of cleaning agents, dust, particulates and lubricants, as well as dust from previous products [1]. Contamination and cross-contamination can be prevented by ensuring that adequate cleaning procedures are followed properly.…”

Section: Introductionmentioning

confidence: 99%

A Brief Review On Cleaning Validation-Regulatory Guidelines For Pharmaceuticals

Patra¹

2022

Journal of Pharmaceutical Negative Results

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Cleaning validation is a process used by pharmaceutical manufacturers to ensure that their equipment and facilities are thoroughly cleaned and free of any residual contaminants that could potentially compromise the quality of their products. This process is guided by regulatory guidelines set forth by FDA and European Medicines Agency (EMA) are two examples of such agencies. Cleaning validation protocols are typically required by these guidelines, which outline cleaning procedures, acceptance criteria for evaluating the effectiveness, as well as testing and documenting the results. The protocol should also include a risk assessment to determine which equipment and areas of the facility are most critical to the product's quality and safety. Manufacturers are also expected to periodically review and update their cleaning validation protocols as necessary, and to keep detailed records of all cleaning validation activities. A manufacturer's cleaning validation protocol and the presence of contaminants may also be verified by FDA or EMA inspections. To ensure consistently high quality, pharmaceutical manufacturers must control cross-contamination. There must be a comprehensive cleaning regime in place to demonstrate that the methods employed in a facility consistently control the carryover of product (including intermediates and impurities), cleaning agents, and extraneous material into subsequent products. An effective cleaning regime provides documented evidence that these aspects are consistently controlled within a facility. As a pharmaceutical manufacturer, it is your responsibility to ensure that your cleaning process complies with cGMP regulations, first and foremost.

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HPLC Method Development and Validation for Residue Analysis of Steroid

Das Sharma,

CH,

Verma

et al. 2023

RJPT

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A High-Performance Liquid Chromatography technique was developed for Residue Analysis of Megestrol Acetate collected from pharmaceutical manufacturing equipment’s. The samples were collected by Texwipe swab, separated by using Primesil C18 150mm x 4.6 mm, 5µm (Part No.: PC181504650) stationary phase and 65:35 of Acetonitrile: water as mobile phase in isocratic mode of elution. The residues were extracted from the swab in ultrasonic bath and later determined at a wavelength of 280nm. The detection was done using PDA detector for improved sensitivity. The developed method was then validated depending on the parameters of Cleaning Validation suggested by FDA. The method was found to be linear in a concentration range of 0.03-15 μg/ml. RSD of six replicates (Precision) were found to be 1% and the Recovery was found to be >90%. This method can be used to determine trace residues by Megestrol Acetate API on the manufacturing equipment’s in order to avoid any cross contamination during batch manufacturing.

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A Review on Cleaning Validation-Regulatory Guidelines for The Pharmaceutical Industry

Cited by 6 publications

References 0 publications

The Mechanism of Drug Carryover in Feed Manufacturing as a Function of Drug Properties and Equipment Design—A Brief Review

The Mechanism of Drug Carryover in Feed Manufacturing as a Function of Drug Properties and Equipment Design—A Brief Review

A Brief Review On Cleaning Validation-Regulatory Guidelines For Pharmaceuticals

HPLC Method Development and Validation for Residue Analysis of Steroid

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