Cleaning Validation Memos from 2008

2008

Solvent Reflux Sampling Recovery

A general principle for cleaning validation protocols is that if you utilize a certain sampling technique to measure residues that are then compared to acceptance criteria (limits), then it is necessary to perform a sampling recovery study to confirm that the sampling method appropriately measures residues if they were present. This is covered by the […]

Nov

2008

Limits for Topicals

This Cleaning Memo addresses cleaning validation limits for topical dermatological finished drug products. Since the typical dose-based (or carryover) calculation involves the dose of the cleaning product active as well as the dose of the next manufactured product, the key question is how those doses are defined, specifically, if the two drug products can be […]

Oct

2008

Are We Setting Limits Correctly?

This Cleaning Memo is a shortened version of my recent (August) webinar of the same title. The way limits are currently set for cleaning validation protocols has been critiqued by Andy Walsh (of Clean6Sigma) as not risk-based, as not science-based and as arbitrary. This critique was given in presentations at an ISPE conference this summer, […]

Sep

2008

Sampling Recovery for Biotech

The focus of this Cleaning Memo is the issue of what residue to spike onto coupons for sampling recovery studies (whether they be swab sampling recoveries or rinse sampling recoveries) for biotechnology manufacture. The ideal is to spike the residue that will be sampled in the cleaning validation protocol. With small molecule drugs, for example, […]

Aug

2008

Do Three Verifications Make a Validation?

The traditional approach to validation, including cleaning validation, is to perform a minimum of three validation runs. Of course, there is no statistical justification for three runs being acceptable. It is just something that pharmaceutical manufacturers and regulatory authorities have agreed on. In some regulatory documents (for example, the European PIC/S PI 006-03), it is […]

Jul

2008

What’s Happening to Revalidation?

At the recent PDA annual meeting, a representative of the FDA mentioned that in the upcoming FDA revised process validation guidance, the term “revalidation” will no longer be used. What’s behind this move? And will it apply to cleaning validation? The latter question is probably easier to consider. Cleaning is just another manufacturing process, and […]

Jun

2008

Still More on Floors and Walls

Last month’s Cleaning Memo elicited more responses than usual. Therefore, I am taking the liberty to wait until July to talk about “revalidation”, and will continue to discuss the issue of setting limits for and measuring residues on floors and walls. Two basic assumptions in last month’s Cleaning Memo were (a) that floors and walls […]

May

2008

More on Floors and Walls

I am hearing more and more about regulators asking questions about measuring residues for non-product surfaces such as floors and walls. Is that an appropriate question to ask for a cleaning validation program? My answer is “No”. Is that an appropriate question to ask a pharmaceutical manufacturer? My answer is “Yes, under certain circumstances”. Why […]

Apr

2008

What Have We Learned in the Last Two Decades?

Cleaning validation for pharmaceutical manufacturing is no longer in its infancy. Several months ago, in a Cleaning Memo, I discussed two papers on cleaning validation that were published in the 1980s. Different dates could be proposed for the official “birthday” of cleaning validation, but the early 1990s are fairly close, with the Barr Labs decision […]

Mar

2008

Canada’s Revised Guidelines

Health Canada issued revised cleaning validation guidelines on January 1, 2008. Here is a link to those guidelines: https://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui-0028_cleaningnettoyage_ltr-doc_e.html (You can also find them under the “Resources/Specific documents” section of this website.) This document keeps the same structure and most of the same basics as the previous version, with the following changes. The changes listed […]

Feb

2008

A Stroll Down Memory Lane

You’re probably thinking I have “lost my marbles” with this title, saying, “What is this Cleaning Memo about?” Well, over Christmas break, I had the opportunity to write three chapters for an upcoming book on cleaning validation. One of the chapters was an introductory chapter, and as part of that, I reviewed what was said […]

Jan

2008

Can Protocols Use Limit Tests?

A general practice in cleaning validation protocols is to use analytical methods that can effectively measure a certain residue over a defined range. In the analytical method validation, it is generally the practice to establish that the measurement of the residue is linear over the defined range. This applies whether the analytical method is a […]

Memo Year: 2008

Destin LeBlanc has been publishing memos on Cleaning Validation since 2001.

Solvent Reflux Sampling Recovery

Limits for Topicals

Are We Setting Limits Correctly?

Sampling Recovery for Biotech

Do Three Verifications Make a Validation?

What’s Happening to Revalidation?

Still More on Floors and Walls

More on Floors and Walls

What Have We Learned in the Last Two Decades?

Canada’s Revised Guidelines

A Stroll Down Memory Lane

Can Protocols Use Limit Tests?

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