Cleaning Validation Memos from 2011

2011

The Good, the Bad and the Inexplicable of Risk-MaPP

Your mom told you the same thing my mom told me: “Always say something positive about something before you say something negative”. Well, I’ve said enough negative things about Risk-MaPP, so it’s time I said something positive (don’t worry, I will also fulfill the second half of her admonition later in this Cleaning Memo). The […]

Nov

2011

Limits Below the LOD in Rinse Solutions – Part 3

This Cleaning Memo continues the thought processes in Part I and Part II, but goes beyond just the consideration of dealing with issues relating to the LOD/LOQ of the analytical method being too high. What I’m doing in Part III is discussing something related, but somewhat different. In the previous Cleaning Memos, I discussed cases […]

Oct

2011

Limits Below the LOD in Rinse Solutions – Part 2

This Cleaning Memo continues the thought processes in Part I (the September 2011 Cleaning Memo) by discussing applications to CIP rinsing. If you remember, the situation is this. I have established limits in my rinse sample based on carryover calculations, and the limit is X ppm. However, my analytical method can only detect down to […]

Sep

2011

Limits Below the LOD in Rinse Solutions – Part 1

Okay, this is another squirrelly Cleaning Memo on using scientific principles (and logic) to deal with a situation that otherwise could cause heartburn. The situation is this. I have established limits in my rinse sample based on carryover calculations, and the limit is X ppm. However, my analytical method can only detect down to a […]

Aug

2011

More on an Alternative Swab Recovery Procedure

The May 2011 Cleaning Memo was on an alternative procedure for determining swab recovery percentages. I had several comments and questions on that alternative, so I considered it best to provide an additional perspective on that procedure. I will not repeat the details of the procedure here. Go back and review the May Cleaning Memo […]

Jul

2011

Manual Cleaning Issues – Part 2

This Cleaning Memo is a continuation of last month’s Cleaning Memo on the subject of special issues for manual cleaning. Last month, I gave a definition for manual cleaning and discussed issues related to the classification of cleaning processes based on their degree of automation and the location of cleaning. One reader brought up the […]

Jun

2011

Manual Cleaning Issues – Part 1

As recognized in both the FDA and PIC/S guides on cleaning validation, there are special considerations that should be taken into account for cleaning validation of a manual cleaning process. This Cleaning Memo will address issues related to the definition of manual cleaning, as well as issues related to obtaining consistency in manual cleaning. The […]

May

2011

An Alternative Swab Recovery Procedure

The traditional approach to swab recovery studies is to perform them before approving a cleaning validation (or cleaning verification) protocol. They may be done either as part of an analytical method validation or as a separate study after the analytical method is validated. There may be situations where this is not practical (because of scheduling […]

Apr

2011

A Conundrum Regarding Limits

There are lots of Cleaning Memos stored somewhere in my brain that don’t come to light until I get relevant questions on the subject. The issue of “residues of multiple actives” is one of those things that I have considered in the past, but with all the other problems in cleaning validation, it has never […]

Mar

2011

What Does the FDA Process Validation Guidance Say about the Number of Qualification Runs

I find myself again in a position where I have to change the planned Cleaning Memo in order to address a critical issue about validation. That issue involves the FDA process validation guidance, issued in draft form in November 2008 and issued as “Revision 1” in January 2011. Specifically, what do those documents say about […]

Feb

2011

More on ISPE Risk-MaPP

As stated in my November 2010 Cleaning Memo, I have serious problems with the ISPE document “Risk-Based Manufacture of Pharmaceutical Products” (Risk-MaPP). My primary objection is not related to using a health-based limit for highly hazardous actives; that is something I also teach. My primary objection is to “collateral” statements made in the document related […]

Jan

2011

More on Campaign Length

Last month I gave one example related to “understanding the cleaning process” that deals with campaign length. I said if there is adequate evidence that campaign length (defined as the number of batches and/or elapsed time) has no effect on the difficulty of cleaning, then performing all qualification runs after just one batch may be […]

Memo Year: 2011

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

The Good, the Bad and the Inexplicable of Risk-MaPP

Limits Below the LOD in Rinse Solutions – Part 3

Limits Below the LOD in Rinse Solutions – Part 2

Limits Below the LOD in Rinse Solutions – Part 1

More on an Alternative Swab Recovery Procedure

Manual Cleaning Issues – Part 2

Manual Cleaning Issues – Part 1

An Alternative Swab Recovery Procedure

A Conundrum Regarding Limits

What Does the FDA Process Validation Guidance Say about the Number of Qualification Runs

More on ISPE Risk-MaPP

More on Campaign Length

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