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USP General Chapter <797> Revision: Where Are We Now?

A vital chapter to the sterile compounding community – USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations – is in the process of a major revision. 

Although the released revision is only in the proposal phase, it’s critical that compounding facilities start planning and preparing for the release of the new chapter. 

How can you prepare for the proposed changes? 

Cleaning Validation FAQ

Cleaning validations are completed to prevent contamination and cross contamination by providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels/ acceptance criteria.

Gowning for USP <797>

A critical aspect in maintaining a state of control in a USP < 797> compliant cleanroom is gowning appropriately.  Here are some important tips to consider when drafting your gowning SOP.

Important Considerations when Performing a Microbial Cleaning Validation

A sound cleaning and sanitization program is required for GMP facilities that manufacture or process products under FDA regulations. A portion of the requirements are addressed in the USP<1072> chapter. Disinfectants used in these facilities need to meet several requirements, many of these requirements are completed by the manufacturer of the disinfectant. However the user of the disinfectant must provide evidence that the disinfectant is effective on the materials found in the facility as well as on the resident microorganisms.

ISO 9001 Revisons for 2015

Significant changes in key areas should make the new ISO 9001:2015 standard more practical and simpler to use once implemented.

Quality in Sample Packaging and Why it Matters

Perhaps the most easily overlooked quality aspect of environmental sampling is proper packaging. Even the most seasoned technicians and experts in aseptic technique can end up with contaminated samples due to improper packaging.

Sources of Contamination in a Clean Room

Cleanroooms are designed and built to maintain a state of control of viable and particle levels during manufacturing or production. Cleanrooms are consistently monitored to assure these levels are maintained.  What are the major sources of viable contamination found in the cleanroom?

Taking the Mystery out of the Chain of Custody

How many times have you received a call or email from your laboratory asking for additional information which was not included on the Chain of Custody, or to let you know that what was stated on the Chain of Custody was not what was actually received? Unfortunately this is a common problem, but taking the time to properly complete the Chain of Custody will aid in lessening the frequency of these calls and emails.