Pharma Blog

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Pharma Blog 2018-02-26T09:29:08+00:00

PHARMA/BIOTECH

BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…

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  • Warning Letters

Week of June 10th 2018 | FDA Sent This Warning Letter to a Pharma Company

June 22nd, 2018|

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below: Want to see the complete list of enforcement documents — including [...]

  • ALCOA

How Do I Apply ALCOA To E-Records?

June 21st, 2018|

It’s easier than you think! Let’s... Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the Paper World [...]

  • GMP Scan

GMP Regulatory Newsletter: Summary Scan | Week of 6/10/18

June 20th, 2018|

Laws, Regulations, Guidance, and Concept Papers A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material! Among the most important from the FDA [...]

706, 2018

Part 2: The FDA and MHRA’s Most Recent Drug Inspection Observations

June 7th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Warning Letters, Form FDA 483, Medical Devices|

Continued from Part 1... FDA 483 INSPECTION OBSERVATIONS: It all starts with Table 1... Table 1 shows the fifteen (15) most frequent inspection observation citations (the tabulation on the FDA website shows all). Table 1 presents data in the order of those observations with the highest to lowest number for 2017, modified as described in the ‘Introduction’ section of [...]

606, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 5/27/18

June 6th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers This was a short week in the US with the Memorial Day holiday on Monday: The FDA published 6 guidance documents WHO published 1 EMA didn’t publish any in the areas we monitor The non-guidance collection includes the usual from the FDA, EMA, MHRA, and HPRA this week Among the more important announcements [...]

506, 2018

88 New FDA 483s | June 5th 2018

June 5th, 2018|Categories: Biopharma / Pharma, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Sign up for your risk-free trial of the leading GMP intelligence newsletter. Like This & Want More? Sign up to get free weekly content updates designed to make your [...]

106, 2018

Week of May 20th 2018 | FDA Sent These Warning Letters to Pharma Companies

June 1st, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 12 warning letters this week. Many were issued for unapproved new drugs/misbranding deficiencies. We address 4 below that focused on GMP deficiencies. CELLS/TISSUES: Emmett F. Branigan MD PS Inc (Bellingham, WA) received a warning letter dated May 7th 2018 based on the outcome of an inspection ending January 31st 2018. Though not stated directly, it appears that [...]

3105, 2018

See You At ISPE

May 31st, 2018|Categories: Biopharma / Pharma, CGMP, FDAzilla|

Govzilla is on the road again! I hope to see you at the International Society for Pharmaceutical Engineering (ISPE) Quality Manufacturing Conference in Arlington, VA from June 4th - 6th. I am excited because this conference will be tackling challenges in quality manufacturing with a special emphasis on the global manufacturing environment. Everyday I speak with our customers from all [...]

3005, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 5/20/18

May 30th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers: FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011. EMA published 1 on IMPs for consultation. HPRA, WHO, Health Canada, and CDSCO each published 1. To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence [...]