Good manufacturing practice gmp is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards. BPF. Bonnes pratiques de fabrication. BPL. Bonnes pratiques de laboratoire. BRIC. Brésil .. qui a été réaffirmée lors de la 5ème réunion en Namibie en . Loi n° du 22 mars portant diverses dispositions d’adaptation de la Des établissements pharmaceutiques (EP) privés (L. ). ◇ Des établissements publics . BPF médicament (?). (Décision en cours).
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Le site ne peut pas fonctionner correctement. There is no question that drug manufacturers should provide evidence that room decontamination programs achieve and maintain desired contamination control levels.
This paper will provide considerations and discuss best practices for validating disinfectants used in drug manufacturing areas. It is important to understand that disinfec- tant validation is a process that includes three distinct components. These compo nents are: Because there are a number of variables that can impact disinfectant performance under actual use conditions, it is important to conduct in vitro studies to demonstrate that a particular product is inherently effective against a par- ticular organism under well-defined conditions, such as concentration and contact time.
Most countries require in vitro testing in order to register and market a disinfectant or sporicidal product.
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The product labeling reflects the particular organisms e. American Type and Culture Collection or ATCC strains that were included in these studies, and the specific conditions under which testing was conducted e. However, the testing required for product registration typically does not meet the needs of pharmaceutical manufacturers who must comply with regulatory expectations. Demonstrating effectiveness on materials of construction that are representative of actual manufacturing surfaces e.
The condition and composition of the surface can have an adverse impact on the performance of the disinfectant for a number of reasons, e. Warning Letter January 29, In vitro testing When considering several potential disinfectants or sporicidal agents, it may be prudent to begin in vitro testing with suspension studies.
A suspension study in its most simple form involves exposing a known inoculum of a specific organism to a known concentration of disinfectant or sporicide, for example, for a specified period of time.
Once the suspension studies are complete, a comparison of effectiveness of various products should allow selection of a limited number of highly effective products that can then pharkaceutique included in more rigorous testing, including coupon studies representing the materials of construction MOC of areas or equipment to be treated.
In particular, the regulators have expressed concern about the selection and condition of MOC failing to represent both the actual MOC and the condition of such materials in manufacturing areas. A bbpf FDA warning letter stated: Aluminum found in classified areas used to manufacture sterile products. When developing a testing matrix, it is important to consider MOC that fairly represent the manufacturing surfaces and that represent the condition of the surfaces.
In an ideal world, damaged surfaces would be immediately repaired or replaced. However, this is not always possible, and if damaged surfaces are to be kept in use for an extended period of time e.
In addition to the MOC and condition of coupons, selection of environmental isolates to include in testing is a key consideration. Selection should include organisms most commonly isolated from manufacturing surfaces and personnel e.
In the event that a facility is newly operational and a substantial body of isolates has not yet been established, inclusion of a broad spectrum of organisms sourced from ATCC, for example, may be considered. In addition to MOC and isolate selection, regulators will also pbarmaceutique other aspects of the in vitro work including, log reduction goals and results, recovery and neutralization studies, and controls.
The study design and method used for in vitro testing of disinfectants by a pharmaceutical manufacturer must be carefully planned and be scientifically justifiable to the regulatory authorities. Unfortunately, there is not one perfect testing method. However, there are several published methods that do provide good general information for performing these studies and that can be modified and adapted for use in disinfectant qualification testing.
These methods utilize stainless steel disks other surfaces can be adapted inoculated with the challenge bpr that are treated with the disinfectant followed by neutralization and quantitation of survivors in order to establish the activity of the product.
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In situ testing In situ testing demonstrates that the disinfectant or sporicidal agent in conjunction with preparation procedures and application procedures used by the facility and employees are effective at maintaining the environmental microbial levels deemed necessary for production of the target product. For example, pharmaceuitque firms will compare environmental data pre and post decontamination after a preventative maintenance shut-down, when the room is more likely to show relatively high levels pbf environmental contamination.
Clearly, the personnel who are assigned to perform these functions, must have sufficient training and oversight.
Environmental monitoring and trending Environmental monitoring practices, including frequency, location, and number of samples per sampling interval, should be based upon best available guidance documents and a valid scientific rationale bpt to the type of product being manufactured.
That being said, a single day of environmental monitoring data is but a snapshot in time, and cannot, alone, convey much useful intelligence about the state of control of a manufacturing area. Ongoing environmental monitoring, with data trending, is further validation that a holistic contamination control pharmaceutjque is effective.
It is recommended that any organisms detected be identified to the species level, and that pyarmaceutique be stored for inclusion pharmqceutique future in vitro studies. Data should be reviewed periodically for negative trends; once a month is a common frequency.
Additionally, criteria must be established for identifying a negative trend. However, there is no procedure that defines the search criteria for trending. No evaluation of environmental monitoring data for the support areas within the aseptic core were conducted during the investigations. Summary Disinfectant validation is a process that includes in vitro studies, where the disinfectant or sporicidal agent can be evaluated under highly controlled conditions; in situ evaluations which demonstrate how effective the disinfectant or sporicidal agent pharmaceutiqke under actual use conditions typically conducted in a worst-case environment ; and routine environmental monitoring with trending and assessment of negative trends.
While there is no single regulatory or advisory document available that pharmacetique a blueprint for development of a disinfectant validation study, there are several documents and references, including FDA observations and Warning Letters, which both highlight pitfalls and offer solid input on study design.
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Prenez-vous trop de risques? His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Polarine is a frequent industry speaker and published several book chapters and articles related to cleaning and disinfection and contamination control.
He is active on the PDA task force on cleaning and disinfection and the PDA task force on Microbial Deviations and a co-author on the technical reports.