Q Laboratories’ Director, Pharmaceutical & Personal Care Services, Cathleen Owen will be speaking at two industry events in early May.
On May 3, at the Personal Care Products Council Legal & Regulatory Conference, Cathleen will be included on an expert panel discussing the role of Quality Agreements for outsourced operations as part of Good Manufacturing Practices (GMPs) for cosmetics.The panel will examine the benefits and regulatory expectations associated with implementing Quality Agreements as a best business practice.Cathleen will be joined on the expert panel by Paula Katz, an FDA Regulatory Attorney with the Washington D.C. firm Covington and Burling, LLP., and Tim Parrent, Group Leader - Quality Systems at Mary Kay.The Conference will be held at the St. Anthony Hotel in San Antonio. To register visit the event website
NYSCC Suppliers' Day
On May 8th, Cathleen will speak at the New York Society of Cosmetic Chemists (NYSCC), Innovation & Compliance Conference in New York City. She will discuss the importance of implementing GMPs across the entire supply chain, and how having an effective GMP program is critical to consistently manufacturing products to a quality appropriate for their intended use.Coinciding with the NYSCC Suppliers' Day 2019 event, the Innovation & Compliance Conference will focus on Essential Elements of Cosmetic Regulation, Safety Assessment, and Quality Assurance. The US Personal Care Products Council along with the German Cosmetic, Toiletry, Perfumery, and Detergent Association are organizing the Conference.If you are attending the NYSCC Suppliers' Day Event, be sure to stop by Booth #117 and learn about some exciting things happening at Q Laboratories.For more information on NYSCC Suppliers' Day or to register for the event, visit the event website
An antimicrobial or preservative is defined as a chemical agent that will kill or inhibit the growth of microorganisms. Common antimicrobials utilized in drug, OTC, cosmetic, and personal care products include parabens, alcohols, and quaternary ammonium compounds. Antimicrobial Effectiveness Testing (AET) also known as Preservative Efficacy Testing (PET) is microbial challenge methodology performed to assure the preservative in a product, or the antimicrobial action created by the properties of a product, is sufficient to combat the introduction of microorganisms. There are multiple methods available for performing this testing including, USP <51> Antimicrobial Effectiveness Testing, ISO 11930 - Evaluation of the Antimicrobial Protection of a Cosmetic Product, and Personal Care Products Council Methods M-3 to M-7. (more…)
As the weather warms and the sun peeks out from behind the clouds, thoughts turn to outdoor activities and enjoying the pleasant weather. What follows is the inevitable need for sunscreen/sunblock products to help keep consumers and their families safe. This requires sunscreen product manufacturers to perform due diligence to assure the products they place on store shelves provide the level of protection indicated.
This process involves many steps. First of all, testing to determine that active sunscreen ingredients meet acceptable standards of raw material identity and purity according to USP/NF guidelines, prior to formulating them into the product(s). Having a qualified laboratory verify the active ingredients (e.g. Octinoxate, Oxybenzone, Avobenzone, Octisalate, Octocrylene, Homosalate, Zinc Oxide, etc.) meet the standards defined by USP/NF is an important step in assuring the quality of the finished products. This can be accomplished by periodically sending raw material lots to a laboratory to perform the USP/NF Monograph(s) or by requiring the raw material supplier to provide a Certificate of Analysis with the raw material shipments. Even if the supplier provides this C of A, it is recommended to occasionally have lots independently tested for verification.
Once the Sun Protection Factor (SPF) of a formulation has been determined, testing random lots of finished product is another step to assure product integrity. A qualified laboratory can develop and validate an assay that quantifies the levels of the active ingredient(s) and this assay is then utilized to monitor the levels of the actives as finished products are produced. A validated assay is required for each product type, even if the active ingredient(s) are the same if the excipients are varied, a targeted assay must be developed. An experienced lab can save time and money by using previously developed assays as building blocks to develop and validate the specific assay for each product type.