Serialization: What It Means for Pharmaceutical Manufacturing

Posted by Peter Lunde

In the pharmaceutical industry, counterfeit and falsified drugs pose a global public health risk. These drugs may be not only ineffective but actively dangerous, causing adverse reactions or even death. Furthermore, these counterfeit drugs may be manufactured in multiple locations — e.g., chemical synthesis in one country, the addition of fillers in another and packaging in a third — making them difficult to track and remove from the supply chain.

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Topics: packaging, serialization

How to Maximize Pharmaceutical Manufacturing Quality From Your Employees

Posted by Joanne Richard

In pharmaceutical manufacturing, a number of measurable factors affect quality. An organization can invest in state-of-the-art facilities, robust operating procedures and a sophisticated IT infrastructure, but it should also keep in mind that employees’ roles, responsibilities and the organizational structure play a large part in manufacturing success.

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Topics: quality, Corporate Culture, pharmaceutical manufacturing, employee retention

How to Use Pharmaceutical Manufacturing Metrics to Measure Quality

Posted by Joanne Richard

In drug product manufacturing, quality is everything. Inconsistent quality can result in manufacturing delays, additional costs and a shortage of available products. Preventing and swiftly resolving any issues will benefit many stakeholders — including the client, the manufacturer and, ultimately, the end user of these products.

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Topics: quality, key performance indicators, best practices, metrics, compliance

Five-Point Checklist for Pharmaceutical Scale-Up

Posted by David Watt and Norm Fong

Scale-Up Blog Series, Part 3

[Editor’s note: Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. This is part 3 of an in-depth, multi-part series on product scale-up. Visit our blog page to read parts 1 and 2.]

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Topics: CMO Partner, excipients, scale-up, Process Development, SUPAC, Registration Batch

Introduction to Scale-Up and Post-Approval Changes (SUPAC)

Posted by Norm Fong

Scale-Up Blog Series, Part 2

[Editor’s note: Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. This is part 2 of an in-depth, multi-part series on product scale-up. Visit our blog page to read part 1.]

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Topics: scale-up, Pilot Batch, Process Development, SUPAC, batch, Documentation, Stability Testing

Practical Considerations in Pharmaceutical Production Scale-Up

Posted by Norm Fong

Scale-Up Blog Series, Part 1 

Assuring-Technology-Transfer-Success-eBook

From first-in-human and through each of the clinical trial stages and into commercialization, scale-up of formulation design is a natural part of pharmaceutical development. At each stage of process development, the batch size increases, from laboratory-scale batches that may be quite small to support preclinical and early clinical stages, to pilot batches that are used in process development, and finally to the production-scale batches needed to support commercialization.

Not surprisingly, the size, speed and power of the equipment involved in production has a significant impact on the entire process and must be matched to the batch-size requirements for production efficiency. Regardless of the size of the batch and its application — for use in clinical trials and stability testing, to service a smaller patient population with an orphan drug, or to provide for a larger population with a commercial product — the object is always the same: the finished product must be identical to the original formulation design regardless of the volume under which it is was produced.

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Topics: scale-up, Pilot Batch, Validation Batch, Process Development, SUPAC, Registration Batch, Feasibility Batch

Part 7 — How Does the FDA's Process Validation Guidance Simplify a Technology Transfer?

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 7 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: qualification, PV, process validation, IQ, FDA guidance, OQ, PQ

Part 6 — In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 6 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: due diligence, excipients, development reports, in-licensing, API, complaint history, USP standard

Part 5 — The Cost of Getting a Technology Transfer Right

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 5 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: MSA, confirmation/demonstration batch, QA, Regulatory site audit, capital expenditure, legal fees

Part 4 — How are Analytical Methods Exchanged in a Technology Transfer?

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 4 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: CMO, analytics, analytical method transfer, chemical analytics, validation