Source: http://www.cleaningvalidation.com/Resources/CGMP/Sept2000.aspx
Timestamp: 2013-05-19 18:27:32
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CVT - CGMP September 2000
Cleaning Memos
More on Limits Based on Compendial Water Values
The 500 ppb TOC Myth
Using Safety Factors of Less than 0.001 of a Dose
Does Risk-MaPP Offer More Patient Protection?
Recovery Studies for Different Surfaces for Rinse Sampling
Grouping for Surfaces for Swab Recovery Studies?
Selecting the Number of Validation Runs for Equipment Grouping
Another Critique of Risk-MaPP
Revisiting Limits Based on Process Capability
My Revised Shorthand for Expressing Limits
Differences between Cleaning and Process Validation
Significance of Water Activity for Cleaning Validation
Regulatory Guidances I’d Like to See Changed – Part 2
Regulatory Guidances I’d Like to See Changed – Part 1
How to Completely Avoid Doing Cleaning Validation
How Are ADE’s Determined for Non-Highly Hazardous Actives?
Hold Time Issues
Issues in Cleaning Validation for Parts Washers
The Good, the Bad and the Inexplicable of Risk-MaPP
Limits Below the LOD in Rinse Solutions – Part III
Limits Below the LOD in Rinse Solutions – Part II
Limits Below the LOD in Rinse Solutions – Part I
More on an Alternative Swab Recovery Procedure
Manual Cleaning Issues – Part 2
Where Risk-MaPP Got It Wrong
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’s RiskMaPP
More on Campaign Length
Understanding the Cleaning Process in 2010 (and Beyond)
A Critique of Cleaning Validation Issues in ISPE’s RiskMaPP
More Uses for Visual Limit Determination
Visually Clean and Visual Limits
Statistics for Visual Limits
Acceptable Variability for Sampling Recovery Studies
Final Notes on “Stratified Sampling” More on “Stratified Sampling” Basics of “Stratified Sampling” Revisiting “Cleaning Verification”
What’s an “Equivalent” Swab?
The Rationale for Rinse Sampling for Cleaning Agents
“Continued” vs. “Continuous” Process Verification
Use of Multiple Swabs for Sampling
“Design Space” for Cleaning Processes
The Changing Paradigm for Cleaning Validations
Revisiting Linearity of Swab Recovery Results
Use of Alkali/Acid Cleaning Agents in Biotech
The Science Behind Limits
What’s Happening to Worst-case Process Conditions?
Differing Ways to Express Limits
Another Alternative for Rinse Sampling Limits
Limits for Rinse “Grab” Samples
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
Can Protocols Use Limit Tests?
More on Limits for API Manufacture
Measuring Residues of Volatile Solvents?
Downsides to TOC?
TOC Analytical Method Validation
Master Plans vs. Policies
Spiking Amounts for Sampling Recovery Studies
Issues in Campaigns
Revisiting Medically Safe Limits
Limits for Bulk Biotech Manufacture – Part 2
Limits for Bulk Biotech Manufacture – Part 1
Microbiological Test Method Validation?
Dealing with Deviations in the CEHT Dealing with Deviations in the DEHT
Use of Sampling Templates
CV for General Room Surfaces?
CEHT for Sterilized Equipment
Surface Roughness and Cleaning FTIR with Fiberoptic Sampling
Measuring Bioburden in Protocols
More on Using Rinse Sampling Alone
Separating CEHT Protocols from Cleaning Protocols
Bioburden Proliferation in CEHT Protocols Acceptance Criteria for Dedicated Equipment
Selecting the Swab Sampling Area
Averaging Swab Sample Results?
More on Limits for Formulated Cleaning Agents Issues in Limits for Formulated Cleaning Agents
Revisiting Cleaning Validation for Medical Devices
Setting Limits Based on Process Capability?
Objectionable Microorganism Concept in Cleaning Validation
Cleaning Validation for Packaging Equipment: Part 2
Cleaning Validation for Packaging Equipment: Part 1
Dealing with Unknown Peaks
Establishing Adequate Solubility for TOC Analysis
Is Rinse Sampling Alone Acceptable?
Selecting Worst-Case Products for Grouping
Issues in the Visual Examination of Equipment Surfaces
More on Specificity of Analytical Methods
Cleaning After a Media Fill
TOC Issues: Part 3 – Blanks for Recovery Studies
TOC Issues: Part 2 - Appropriate Blanks
TOC Issues: Part 1 - Sampling Materials
Defining Three “Consecutive” Runs
Endotoxin Issues in Cleaning Validation
Monitoring a Validated Cleaning Process
Correlation of TOC with a Specific Analytical Method?
PAT and Cleaning Validation
Correlation of Swab and Rinse Sample Results?
Why TOC is Acceptable
Adequate “Documented Evidence” for Cleaning Validation
Limits for Drugs with Multiple Actives
What’s Really Different About Biotech?
Using Statistics in Sampling?
Is a Dirty Swab a “Visually Clean” Failure?
Using Sampling Recovery Percentages
More on DEHT Issues
Additional Considerations in Recovery Studies Part 2
Additional Considerations in Recovery Studies Part 1
Recovery Studies for Rinse Sampling
Sampling the Sampling Rinse
Selecting Swab Sampling Sites
Worst-case Process Conditions
Recovery Studies for Microbial Sampling?
Cleaning Validation for Medical Devices
Understanding and Applying “Visually Clean”
What’s a Contaminant?
The Use of Default Limits
The Use of Safety Factors in Limits Calculations 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
Specificity of Analytical Methods
Campaigns and Dedicated Equipment
The Applicability of Cleaning Validation
Human Drug CGMP
Coupons for Recovery Studies
Flexible Fiberoptic Scopes
High Pressure Equipment Cleaning Systems
In-line UV for Cleaning Monitoring
Microbial Identification Labs
Tank or Bin Liners
TOC Instruments
Ultrasonics: Consoles for Parts Washing
Ultrasonics: Immersible Transducers for Tank Cleaning
Vials for TOC sampling
Cleaning Memo pdf
Residue Software
Purchase Cleaning Memos
HUMAN DRUG CGMP NOTES EXCERPT
How can one obtain a copy of the procedures for detecting and measuring penicillin contamination in drugs?
Reference: 21 CFR 211.176, Penicillin Contamination; FDA By-Lines No.3, Nov. 77, A Review of Procedures for the Detection of Residual Penicillin in Drugs.
The bioassay referenced in 21 CFR 211.176 can be used whenever there exists a reasonable possibility that a non-penicillin drug product has been exposed to cross-contamination with penicillin. The non-penicillin drug product should be tested for the presence of penicillin and not marketed if detectable levels are found when tested according to procedures specified in “Procedures for Detecting and Measuring Penicillin Contamination in Drugs”, which is incorporated by reference. Copies are available from the Division of Pharmaceutical Analysis, (HFD-923), Center for Drug Evaluation and Research, Food and Drug Administration, 8301 Muirkirk Road, Laurel, MD, 20703. To request copies of the procedure contact:
Valarie A. Flournoy, Tel 301-827-8236, FAX 301-827-8073, E-Mail FLOURNOY@CDER.FDA.GOV.
Can section 21 CFR 436.104 (Penicillin Activity) continue to assist in determining residues of penicillin contamination in non-penicillin drugs?
Reference: 21 CFR 211.176, Penicillin Contamination; FDA By-Lines No.3, Nov.77, A Review of Procedures for the Detection of Residual Penicillin in Drugs.
No, it can not. Section 436.104 was in part 21 CFR 436. Parts 429 through 460 existed for the purpose of enforcing Section 507 of the FD&C Act “Certification of Antibiotics”. This section of the Act was repealed by FDAMA (FDA Modernization Act). Therefore, section 436.104 was deleted from the CFR and does not exist any longer.
Section 436.104 (methodology for penicillin activity) is derived from the original tests for penicillin contamination in foods and drugs published in FDA By-Lines No.3 (Nov.1977). The FDA codified method continues to exist because it still is required in 211.176 – “…such drug product shall not be marketed if detectable levels are found when tested according to procedures specified in ‘Procedures for Detecting and Measuring Penicillin Contamination in Drugs,…”. The elimination of 436.104 does not change anything for the following reason: In the By-lines, the test sensitivity is stated to be 0.01 units/ml as penicillin G, using S. lutea, equivalent to 0.006 PPM. The ‘standard response line’ cited at 436.104 covers a range of concentrations equivalent to 0.003 to 0.120 PPM, as penicillin G. However, the test method as cited in 211.176 has always indicated a limit of sensitivity of 0.006 PPM. We always indicate that the sensitivity should be at 0.006 PPM and not necessarily 0.003 PPM. So nothing has changed because the By-lines also covers a range of concentrations which can be used as ‘standard response lines’ similar to 436.104.
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