MANUFACTURING ENVIRONMENT TESTING
Releasing contaminated products poses an enormous risk to consumer safety and your brand’s reputation. Manufacturers are beginning to be held accountable for the quality of their products. With many personal care products being classified as over-the-counter drugs, increased regulatory oversight requires companies to adopt cGMP quality control standards aligning with current regulatory demands on the pharma industry. Cosmetic manufacturers must be concerned about the safety of personal care product ingredients, inspection of facilities and records, and developing good manufacturing practices.
YOUR FORMULA OR THE ENVIRONMENT? To adopt cGMP in a production environment, most manufacturers must undertake a series of upgrades to improve their quality system, production process and product release testing.
In the past, these improvements were frequently dismissed as too expensive and resource- dependent to implement. Though the upfront cost of implementation may be relatively high, the risks and long-term costs of using outdated quality testing methods is much higher. The historical methods of manufacturing are no longer acceptable in today’s competitive market. In order to move away from a manufacturing philosophy that inherently carries a certain level of risk, quality must be preserved from start to finish. Raw materials, in-process samples and final product testing should be implemented as part of a good manufacturing process, addressing contamination earlier and faster. For years, the world’s leading consumer care and cosmetic manufacturers have been using a ‘clean-by-design’ process, meeting the demands of consumer trends, ultra-short production cycles and brand protection.
Rapid microbial detection detects microorganisms to confirm quality products in as a little as 24 hours, significantly reducing production time
When production schedules are so tight that products are manufactured and delivered to a store shelf within the same day, there is no room for error. While conventional microbial limits testing is a tried-and-true method, it has its limitations. For maximal regulatory compliance, the standards and principles applied to cosmetic products can be based on those applied in the pharmaceutical industry for non-sterile products. In addition to known objectionable organisms for a particular product, the significance of any microorganism that is recovered from microbial testing should be evaluated to determine whether they are objectionable. In other words, regulators recommend routine environmental monitoring and data trending as a best practice. Bring your manufacturing into today’s age by evaluating the microbial environment of your manufacturing with EM; your facility will switch from reactive to proactive.
Improved test methods, records management and data integrity all play a powerful role in
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meeting regulatory requirements. However, companies often view records management by merely capturing results in any convenient manner and incorrectly assuming the data is sufficient. What they fail to realise is that regulators are increasingly concerned about data integrity and measures need to be taken to ensure data is attributable, legible, real-time, original and accurate.
ACCURATE MICROBIAL IDENTIFICATIONS Detecting contamination in your facility is only the first step in contamination control. Accurate identifications are required to understand the manufacturing microflora, direct appropriate cleaning and disinfecting strategies, and determine contamination risk areas and points of entry. Risk assessments are an important part of qualifications and an appropriate risk assessment cannot be made without an accurate microbial ID. Moreover, assessment of manufacturing qualification cleanliness is not a one-time event. A clean facility should be requalified periodically, especially after any changes to equipment, facility, personnel and/or processes. Requalification provides the opportunity to critically evaluate the microbiological data. Identifications made during this process are just as important as checking the final product to assess and maintain quality in your manufacturing of products.
Being able to review a database of previous results allows users to determine how the contaminant may have gotten into a critical area. For example, an organism found in the contaminated product may have also been found in an air vent within your manufacturing facility and updating air filtration could be a way to remove and prevent any future contamination events.
Having the ability to link isolates with contamination events will aid investigations when out-of-specification (OOS) results are detected, and in ideal cases prevent them from happening. Tracking and trending microorganisms with accurate identification methods in place are key to making proactive decisions in your manufacturing facility. Without tracking and trending, it is difficult to show that procedures put in place for preventing contamination are truly effective. There are many elements to a successful approach in quality risk management and microbiological control that should be based on scientific knowledge.
Having a good understanding of the microflora present is vital. Contamination can come from a variety of sources (eg, personnel, materials, equipment, air and the surrounding environment). When there is a risk of product or process contamination from particular types of organisms, these are considered microorganisms of interest (objectionable organisms).
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