GMP News, GMP guidelines, GMP Violations, GMP warnings A Public Health Global News Portal

Welcome to gmpviolations.com FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters..

150000+ Industry Leaders already read it everyday

Monday, July 24, 2017

FDA Part 211 cGMP Section 22 Responsibilities of quality control unit







Sec. 211.22 Responsibilities of quality control unit.

(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.
(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.


(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

What is Data Integrity ?
What is Meta data?


www.gmpviolations.com
GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal. (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed/ experts experiences sharing.) Disclaimer: The Logos/Images & content posted here are belongs to respective to Authority / owners of firm. The Article posted under public health importance news. Please ensure the guideline as per Regulatory agencies.
Share:

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

AMAZON BEST DEALS

Popular Posts

AMAZON BEST DEALS

Subscribe Free GMP Guidelines

Enter your email address:

Delivered by FeedBurner

Followers

Printfriendly

Subscribe via email for free

Services

Enter your email address:

Delivered by FeedBurner

Contact Form

Name

Email *

Message *

Menu :
Powered by Blogger.

Visitors

    Translater

    Related Posts Plugin for WordPress, Blogger...

    Category

    2016 (37) 2017 (85) 2018 (9) 211 CFR (1) 211.63 (1) 483 (5) AAFA (1) Abbott (2) AboutUs (1) ALCOA (1) Alerts (2) ANDA (1) Anshu (2) Antibiotics (1) apic (1) APR17 (8) APS (2) Articles (4) AstraZeneca (1) Aug17 (2) Aurobindo (2) Author (2) Authors (8) Biocon (1) cadila (1) capa (3) CDSCO (5) Change control (1) Christian Green (1) cipla (2) Cleaning validation (1) Data Integrity (9) dec16 (15) Definations (1) Deviations (1) Donald Trump’s (2) Downloads (17) Dr.Reddy's (4) eca (1) EIR (1) Eli Lilly (1) ema (12) EU (9) FDA (70) FDA Guide (18) FEB17 (15) Genaral (1) General Health (2) GMP (1) GMP News (36) gsk (2) GuidelineEU (10) GuidelinesG (5) GuidelineW (2) GV/0117/001 (1) GVAuthors (3) Health (4) HOSPIRA (1) ICH (3) ICHGuide (3) import alert (1) India (1) ISPE (1) James Bullock (1) JAN17 (23) Jul17 (8) July17 (1) Jun17 (4) Lupin (2) Mahender (39) MAR17 (13) Mar18 (7) May17 (10) MHRA (3) MHRA guide (1) Mumbai (1) Mylan (4) Natco (1) News (55) Non Complinaces (1) Nov16 (5) Novartis (1) oct (1) Oct16 (10) OCT17 (1) PDA (1) Personnel (1) pfizer (1) pics (8) Picsguide (2) QbD (1) Quality Docs (1) RCA (1) Recall (1) safety (1) Sanjeev Kumar Singh (4) Sanofi (1) Sep16 (6) Siegfried Schmitt (2) SUN (1) TGA (3) TOP 10 PHARMA (1) USP (2) Validation (3) Warning Letters (43) WHO (6) zika (1)

    Sponsors

    Theme Support