Content by The QA Pharm
Selling Your ProposalMake it simple and direct
Wed, 03/18/2020 - 12:00
Have you ever wondered why the sales and marketing departments walk out of the boardroom with a bag full of money after they made their pitch, but board members only see you and your quality unit presentation as the bearer of bad news? I have seen…
Weekly Quizzes for Current Good Manufacturing Practices Training CreditComplete all 11 quizzes, and you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training
Mon, 12/09/2019 - 12:02
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit! This is the first of eleven quizzes on CGMPs that will appear weekly on QA Pharm. Try it yourself, and use it as a discussion tool for your…
Three Stages of Quality Management System Implementation and Oversight The most important lessons I’ve learned in pharmaceutical quality assurance during the last 40 years
Wed, 11/08/2017 - 12:01
If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it. When it comes to putting a procedure into written words, it doesn’t mean the words will be effective…
Good Metrics Practice for Quality Management ReviewsData talk—but are you listening?
Mon, 06/13/2016 - 11:45
Aquality management review of data with responsible company leadership is a current good manufacturing practices requirement. Quality management review procedures vary, but there seems to be a struggle with presenting data from across the quality…
Management Responsibility for GMP Oversight and ControlDo you know where your daily operation stands at any given moment?
Mon, 12/07/2015 - 16:06
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the…
Six Methods for Verifying CAPA EffectivenessHow to choose the right method and time frame
Mon, 07/27/2015 - 15:39
Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. It’s reasonable to assume that if a problem is worth solving, it’s also worth verifying…
Four Reasons Companies Come Under a Consent DecreeAnd a short survey to see where yours stands
Wed, 06/17/2015 - 14:42
When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons. 1. Management doesn’t know what is required Executive and senior management might not have regulatory experience…
Twelve Ways to Improve ProceduresNo one should be the victim of poorly written SOPs
Mon, 04/06/2015 - 15:13
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: “We must be OK; we have…
Twelve Ways to Improve ProceduresIt’s okay to say, ‘I can’t follow this procedure, but I know how to make it better.’
Wed, 03/04/2015 - 09:58
At the risk of sounding like a pharmaceutical quality assurance heretic, standard operating procedures (SOPs) often don’t work as intended. In fact, they can do more harm than good by giving a false sense of security: We must be okay; we have…
Finessing an FDA 483, Part 2Organizing to get the work done
Tue, 11/11/2014 - 13:12
Responding to FDA 483 observations was my focus in part 1 of this series. Responses lead to commitments, and commitments lead to changes that are intended to prevent recurrence of the underlying problem that led to the observation. Here, I’ll share…