PBE Expert Inc, we Process, Build, Engineer
PBE Expert Inc
Useful Links
Inspection Guides
- FDA 2011: process validation
- ANSM 2016: guideline on process validation for the manufacture
- PICS: Questionnaire for Assessment
- PICS: 40 years of Co-operation & Mutual Confidence
- PICS: Inspection of utilities
- PICS: Audit Checklist
- ICH guideline Q9 on quality risk management
- The Drug Manufacturer’s Guide to Site Master Files
- Cleaning validation pics guide
- Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
- Good manufacturing practices for pharmaceutical products
- Good manufacturing practices for sterile pharmaceutical products
- Supplementary guidelines on good manufacturing practices: validation
- Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems
- Guideline Q10 on pharmaceutical quality system
- Part 211 Drug GMP
- Guidance for Industry: Sterile Drug Products
- Process Validation: Practical Aspects of the “New” FDA Guidance
CANNABIS links
- Medical cannabis in the treatment of chronic pain
- Medical cannabis significantly safer for elderly with chronic pain than opioidsFDA Warning Letters 2017
- Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids [Health Canada, 2013]
- McGill wants to offer a university degree in cannabis
- McGill offer two workshops on cannabis production
- Eco Cannabis Car
- Marijuana.com informs, engages and grows the cannabis community through coverage of marijuana law + politics, science + medicine, consumer trends, culture and commentary.
Warning Letters
Food Recall Warning
Canadian Food Inspection Agency (CFIA)
- Updated Food Recall Warning – Whole Foods Market recalls Reblochon Cheese “raw cow cheese” due to E. coli O26
- Food Recall Warning – Haute Montagne brand raw milk cheese “Reblochon de Savoie (AOP) au lait cru” recalled due to E. coli O26
- Food Safety Warning – Certain Four Seasons Marketplace brand refrigerated packaged smoked salmon products may be unsafe due to potential presence of dangerous bacteria
- Food Recall Warning (Allergen) – Jongga brand Kimchi Ramen dried soup mix recalled due to undeclared milk
- Food Recall Warning – illy brand whole coffee beans recalled due to swelling cans from missing air valve
- Video: Science in action: protecting people with allergies
- Updated Food Recall Warning – Certain K&K Foodliner brand pork schnitzel products recalled due to E. coli O157:H7
- Updated Food Recall Warning – Certain Greenbelt Microgreens brand microgreens recalled due to Listeria monocytogenes
- “Package Units” Italian Flour Mills
- STERILE DRUG PROCESS INSPECTIONS
- CFR Ch. I (4–1–04 Edition)
- PRE-APPROVAL INSPECTIONS
- GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS
- Computerized Systems in Drug Establishments
- Inspections of Licensed Biological Therapeutic Drug Products
- COMPRESSED MEDICAL GASES
- DRUG MANUFACTURING INSPECTIONS
- DRUG QUALITY SAMPLING AND TESTING (DQST)-HUMAN DRUGS
- OTC DRUG MONOGRAPH IMPLEMENTATION
- ACTIVE PHARMACEUTICAL INGREDIENT (API)
- STERILE DRUG PROCESS INSPECTIONS
- ENFORCEMENT OF THE DRUG SAMPLE DISTRIBUTION
- POST APPROVAL AUDIT INSPECTIONS
- Drug Quality Reporting System (DQRS) (MedWatch Reports)
- GMP Inspections/Audits
- GMP Auditor Training for Quality Systems
- A.T.I. Steam Activated Heat Sensitive Indicators
- Common Values Used in Process Fluid Systems
- Dosage Form Drug Manufacturers cGMPs
- Ethylene Oxide Sterilization 1 Calculation of Initial Gas Concentration
- Foreign Pharmaceutical Manufacturers
- Ground Fault Circuit Interrupter
- Hermetically Sealed Electronic Component Leak Detection
- High Purity Water Systems
- Introductory Issue
- Leak Testing Sealed Ampoules of Parenteral Solutions
- Lyophilization of Parenterals
- Microbiological Pharmaceutical Quality Control Labs
- New Equipment Kenics Static Mixers
- New Source of Lead and Other Contamination
- Noise Control Mufflers for Bleeders on Retorts and Sterilizers
- Oral Solid Dosage Forms Pre/Post Approval Issues
- Oral Solutions and Suspensions
- Pharmaceutical Quality Control Labs
- Steam Distribution for Retort Venting in Food Canneries
- Steam Generation in Canneries
- Steam Pressure for Retorts and Autoclaves
- Sterile Drug Substance Manufacturers
- Sterilizing Symbols (D, Z, F)
- The Computer in FDA Regulated Industries
- Topical Drug Products
- Validation of Cleaning Processes
- Inspection Guides
- Air Velocity Meters
- Bacterial Endotoxins/Pyrogens
- Circular Temperature Recording Chart Measurements
- Electronic Components – Resistors
- Ethylene Oxide Sterilization 2 Graphical Aid to Determine Gas Concentration
- Evaluation of Production Cleaning Processes for Electronic Medical Devices – Part 1, Contaminants
- Evaluation of Production Cleaning Processes for Electronic Medical Devices – Part II, Cleaning Solvents
- Evaluation of Production Cleaning Processes for Electronic Medical Devices – Part III, Methods
- Expiration Dating and Stability Testing for Human Drug Products
- Industrial Applications of a New Biochemical Technology
- Lyophilization of Parenterals
- Measurement of Relative Humidity in the ETO Process
- Microbiological Contamination of Equipment Gaskets with Product Contact
- Pyrogens, Still a Danger
- Radiation Protection Terminology
- Reliability of Manufactured Products
- Temperature Sensors in the Regulated Industry
- The Computer in FDA Regulated Industries – Part II Computer Hardware
- The Nation is Going Metric
- Water Activity (aw) in Foods
- Water for Pharmacuetical Use
- Oral Solutions and Suspensions
- Evaluation Guide for GMP Regulatory Compliance Programme (by Health Canada)
- GMP AUDIT CHECKLIST (AS PER WHO GUIDELINES)
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