Destin A. LeBlanc

Cleaning Validation Technologies

Technical Consulting Services

HUMAN DRUG CGMP NOTES

These documents have been and still are issued by the FDA. Each document contains a number of questions and “unofficial” FDA answers. They cover a variety of topics, among them cleaning validation.

Cleaning Validation Technologies has selected those questions (and answers) that are applicable, either directly or indirectly, to cleaning validation. The issue date and the topic are listed below. Click on a date to see the entire question and answer.

Please note that each “Human Drug CGMP Notes” contains many more questions than are listed on this site. These are only selected sections that deal with cleaning validation issues. In each case where the question and answer are presented, no editing has been done except for the format. For key decisions, it is recommended that the original file or document be consulted.

Detergent limits

Grouping based on materials of construction

BPC validation

Cleaning validation for a biobatch

Preventing objectionable organisms in non-sterile products

Penicillin issues

What investigators look for in CV programs

Acceptance  limits

Manufacture of drugs and non-drugs in same equipment

Rinse sampling

Matrix or family approach to process validation

More on penicillin

Validation of “identical” equipment

More on penicillin

Still more on penicillin

Acceptance limits

Exceeding DEHT

Revalidation/monitoring

Determining residues on uncleaned equipment

Lab glassware validation

TOC for cleaning validation