Cleaning Validation Memos from 2001

2001

What’s a “Dose” for Calculating Limits?

The traditional formulation for finished drug product residue limits for an active involves something like “no more than 0.001 of a minimum dose of the active in the maximum dose of the next drug product”. The question sometimes arises as to how that dose is calculated; is it a single dose or a daily dose? […]

Nov

2001

Cleaned Equipment Hold Time

Last month’s Cleaning Memo covered issues related to the “Dirty Equipment Hold Time” in cleaning validation. This month’s Cleaning Memo covers issues related to the “Cleaned Equipment Hold Time” (which will be abbreviated CEHT). CEHT is sometimes called the expiration or expiry period for the cleaned equipment. Why is the CEHT important for the control […]

Oct

2001

Dirty Equipment Hold Times

There are two aspects of “hold times” generally evaluated for validated cleaning processes in pharmaceutical manufacturing. One is the time from the end of manufacturing until the beginning of the cleaning process. The other is the time from the end of the cleaning process until the beginning of the use of the cleaned equipment for […]

Sep

2001

Handling Sampling Recovery Results

This “Cleaning Memo” addresses how to handle sampling recovery data in a cleaning validation protocol. This includes both swab sampling recovery percentages and rinse sampling recovery percentages. Sampling recovery is a quantitative measure (usually expressed as a percentage) of the portion of target residue on a surface that can be removed by the sampling procedure […]

Aug

2001

Equipment Grouping Strategies for Cleaning Validation

The purpose of “equipment grouping” for cleaning validation is to simplify validation in cases where there are multiples of either “similar” or “identical” pieces of equipment or equipment trains. The objective in equipment grouping is to classify the different pieces of equipment as “identical” for cleaning validation purposes so that it is not necessary to […]

Jul

2001

Product Grouping Strategies for Cleaning Validation

The purpose of “product grouping” for cleaning validation is to simplify validation in cases where there are a large number of “simi ar” products made on the same equipment and cleaned using the same cleaning SOP. Grouping strategies are not mentioned in the FDA’s cleaning validation guidance document; however, in a “CGMP Note” the FDA […]

Jun

2001

Water Quality for Validated Cleaning Processes

The quality of the water used for aqueous cleaning is critical for performance. This includes the water quality for any pre-rinse, for the washing step itself, and for any rinses. What all three of these have in common is the necessity to control the quality of the water used. Quality includes chemical properties (pH, conductivity, […]

May

2001

Setting “Dose” Limits without Dosing Information

There are several situations where this may come up. One includes early clinical trial production of drug actives or finished drug products. In that case the dosing has not yet been fully established. Another involves substances, such as cleaning agents, which have no “dose”. A third case may involve setting limits for degradation products. In […]

Apr

2001

Cleaning for Manufacture of Clinical Trial Materials (CTMs)

The issue of cleaning validation for the manufacture of CTMs frequently comes up in seminars I give. There are two basic topics that are of concern to people cleaning in such a situation. They are the necessity of doing cleaning validation, and the issue of setting limits when the next product (to be manufactured in […]

Mar

2001

The New FDA Compliance Program Guidance Manual and Cleaning Validation

The new FDA Compliance Guidance Manual has useful information on the expectations of the FDA in investigations involving cleaning and cleaning validation. This new program, being rolled out as a pilot program, is designed to more effectively utilize the limited FDA resources to conduct CGMP audits. It generalizes inspection coverage such that inspection of a […]

Feb

2001

Validation of Analytical Methods

Last month we discussed one element – specificity – of analytical procedures used for cleaning validation protocols. This month we’ll cover issues related to method validation. This subject is one that the FDA is paying more attention to in evaluating cleaning validation. In the proposed European guidelines and in the Canadian Guidelines, this topic is […]

Jan

2001

Specificity of Analytical Methods

A somewhat controversial issue in cleaning validation is the nature of the analytical method used to measure residues (such as the drug active or the cleaning agent) in the validation protocol. The crucial issue is whether the analytical method should be (or preferably should be) a specific method. Furthermore, if non-specific methods are allowed, what […]

Memo Year: 2001

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

What’s a “Dose” for Calculating Limits?

Cleaned Equipment Hold Time

Dirty Equipment Hold Times

Handling Sampling Recovery Results

Equipment Grouping Strategies for Cleaning Validation

Product Grouping Strategies for Cleaning Validation

Water Quality for Validated Cleaning Processes

Setting “Dose” Limits without Dosing Information

Cleaning for Manufacture of Clinical Trial Materials (CTMs)

The New FDA Compliance Program Guidance Manual and Cleaning Validation

Validation of Analytical Methods

Specificity of Analytical Methods

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