Mohammed Abdul Jawad

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Reviewing Sterile Products - Examining the Factors Required for Release

Reviewing Sterile Products - Examining the Factors Required for Release

To view this webinar on demand please click here.


Learning Outcomes:
  • Gain an insight into the critical microbiological quality attributes required for the manufacture of sterile products, including bioburden and endotoxin control
  • Assess the physical control factors to support sterile products manufacture, from sterile filter integrity testing to cleanroom certification
  • Understand the types of controls required for fill and finish activities, in line with current GMP
  • Review a holistic approach for batch release based on ensuring there is an assurance of sterility

To download the associated Whitepaper "Reviewing Sterile Products - Examining the Factors Required for Release" please click here.


Introduction 

The associated white paper provides an insight into the critical microbiological quality attributes required for the manufacture of sterile products, including bioburden and endotoxin control. In doing so, the paper presents a holistic approach for batch release based on ensuring there is an assurance of sterility. In addition, this paper assesses the physical control factors needed to support sterile products manufacture, including those that should be considered as part of batch release. This understanding of control extends to the steps necessary for fill and finish activities, in line with current Good Manufacturing Practices (GMP) . 


Batch release is the final part of the manufacturing process and it is the last chance to prevent unsuitable product from being released. One of the most important aspects during the review of an executed batch record is the documentation of any unexpected or atypical events that may have occurred. As well as assessing that the product is efficacious, a sterile product assessment brings with it some additional concerns. 


The presence of microorganisms in pharmaceutical preparations may reduce their efficaciousness or make them unsafe for the patient. The severity of the consequences of having microorganisms present in pharmaceutical preparations differs according to the purpose of the preparation and its route of administration. It is in relation to the severity from the risk of contamination, and due to the route of administration, that sterile products are at the greatest risk from microbial contamination. Assessing the control factors that could impact upon sterility assurance are therefore of great importance for the batch release process. 


The prerequisites for sterile products are: 

1. They are sterile (in all probability, based on the control of sterility assurance) 

2. Pyrogen free (apyrogenic) 

3. Free of visible particles 


Other key quality attributes for sterile products are: 

• Chemical / biological purity 

• Correct dose / strength – correctly labelled 

• Correct physical form e.g. colour, particle size, viscosity 

• No physical contaminants 


Batch release is the process of reviewing and approving all pharmaceutical product manufacturing and control records. It is performed by the Quality Unit to determine compliance with all established approved written procedures before a batch is released. The process of batch release, and the authority and training of the persons eligible to do so, varies according to different GMP systems.


Source: Science with service

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