GMPs require objectionable microorganisms to be minimized in pharmaceutical and biopharmaceutical manufacturing facilities. Unfortunately they do not provide a list of objectionable microorganisms; in fact objectionable microorganisms are not listed anywhere - it's up to each manufacturing site to determine what is objectionable, based upon the products that are produced in the facility. This is not an easy task and can only be accomplished by conducting a risk assessment for each objectionable microorganisms that are found.
This course provides attendees with an understanding of the role objectionable microorganisms play in maintaining the safety and quality of products. We will take participants through a step-by-step process of determining how to assess the risk of an objectionable microorganism, how an objectionable microorganisms affect the safety and quality of in-process products, products already in the market and on the process itself. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing risk analyses for particular products and businesses.
The course offers methodologies and techniques on:
What is an objectionable microorganisms.
Assessing the risk of objectionable microorganisms in excipients.
Assessing the risk of objectionable microorganisms in the environment.
Assessing the risk of objectionable microorganisms in products.
Assessing the risk of objectionable microorganisms in an aseptic environment.
Examples of risk assessments involving objectionable microorganisms.
Who will benefit:
This course was developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials. The course will be especially useful for personnel responsible for:
Research and Development
Quality Assurance & Control
Areas Covered in the seminar:
This course will focus on conducting the risk assessment and will include the following topics:
Definition of an objectionable microorganism.
The difference between pathogenic and objectionable microorganisms.
The risk if an organism is found in a raw material.
The risk if an organism is found in the environment.
The risk if an organism is found in a sterile environment.
The risk if an organism is found in a product.
Factors to consider when conducting a risk assessment
Potential risk from the organism, risk to the product, from the manufacturing process.
Potential risk from the route of administration, from the patient population, from biofilm.
Potential risk to products on the market, risk from customer complaints, risk from adverse events.
Examples will be given on
Oral dosage facility
Aseptic processing facility
Product Safety and Quality
Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their businesses running efficiently and within regulatory guidelines. With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. He learned from the best mentors and brings a unique over site to the industry that has made and saved millions for his clients.