GMP Tips

Writing written procedures that are EFFECTIVE is not a simple task. The best way we’ve seen to ensure that your written procedures are mutually understood and followed is to involve several people when writing and reviewing them. Always include one or more Subject Matter Experts (SMEs). Always include someone from your Quality group. Always include [...]

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Preparing effective written procedures is always a challenge. We’ve discovered some facts about those entering the workforce this year that may make preparing good written procedures and conducting effective training even more challenging. Consider these facts: The people who are entering the workplace or starting college this year were born in 1990. They don’t remember [...]

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There are several ways to keep your GMP training ALIVE after a training session. Here’s one idea. Create Table Toppers with a GMP reinforcement message that you can place on the tables in the lunch room or cafeteria. You can simply print these on heavy card stock and fold them in half and place them [...]

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FLASH! FDA Warning Letters have dropped by half in the past ten years. And recalls have increased. FLASH! The average age of an FDA staffer is 54, and thirty percent are already eligible for retirement. And this week FDA is taking heat for the tomato salmonella outbreak (even McDonald’s announced today that they will not [...]

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FDA and the European Medicines Agency (EMEA) will pilot a joint GMP inspections program under a bilateral agreement. The joint inspections program will apply to facilities in both the U.S. and the European Union (EU). Joint inspections of active pharmaceutical ingredient (API) facilities in countries outside the U.S. and the EU will be part of [...]

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