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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR211.113]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL
PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart F – Production and Process Controls
Sec. 211.113 Control of microbiological contamination.
(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.
(b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
As per US Health & Human Services, the information on this page is current as of Mar. 22, 2024.
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- Shop Comforters, Covers, and Throw Blankets
- Smarter Vitamin D3 - Essential Vitamin K2 Complex
- $500 OFF ALL BATH REMODEL PRODUCTS
- Get $10 off on orders over $250 - Use promo code: INT250 at checkout
- GET A FREE WINDOWS ESTIMATE
- Get 15% off - Limited Quantity Left! Use promo code: CLEARANCE at checkout
- Smarter Vitamin D3 - Smarter Nutrition offers a Premium Plant-Based Vitamin D3, the most absorbable and active form of Vitamin D.
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- Smarter Vitamin D3 - Premium Plant-Based Vitamin D3 – The Most Absorbable and Active Form
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- GET A FREE ROOFING ESTIMATE
- Use code CLEARANCE at checkout
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- Get 6% Off on your first order! Use promo code: WELCOME at checkout
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