GMP TRENDS

A newsletter for pharmaceutical and medical device companies publishing 483 observations made by the FDA during GMP plant inspections.

[GMP TRENDS @GMPTRENDS]

Second person verification is an essential part of GMP compliance. The job of the second person is to ensure the integrity of the data by reviewing the information recorded by the first person.
Read more about second person verification here: https://t.co/7Fr2vzRCl3

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Training should be continuous, allowing your quality team to stay up to date on industry trends and grow in their roles as quality professionals. https://t.co/NX50obmKuo
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#gmptrends #pharmaceuticalindustry #compliance #qualitymanagement #FDA #pharmaceuticalcare

[GMP TRENDS @GMPTRENDS]

Risk analysis involves the identification, understanding, control, and prevention of failures that can result in hazards when people use medical devices.
As part of the design validation process, risk analysis must also be performed and documented. https://t.co/1qERwgHV8w

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Written procedures should assign responsibility and describe in detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities.
Read more here: https://t.co/nK9KvYyHaW

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Proper storage conditions for active pharmaceutical ingredients (APIs) is important to ensure the identity, strength, quality, and purity of the products are not affected. Read more here: https://t.co/89Ar4WHyof

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According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to equipment cleaning (21 CFR 211.67(a), and 21 CFR 211.67(b)) have been in the top 10 observations cited by the FDA each year. Learn more here: https://t.co/rpEeLoMU4f

[GMP TRENDS @GMPTRENDS]

The security of your laboratory’s data plays a major role in the safety of your product, and thus laboratory computer system validation is an important FDA regulation. Check out our latest blog post on validating your lab computer systems here: https://t.co/LTenlh9hKp
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[GMP TRENDS @GMPTRENDS]

You must establish specific hold times for your in-process materials and document any deviations. Read more about a recent 483 observation regarding this topic here: https://t.co/Hl9QtjIk5u

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Did you know each manufacturer is expected to establish and maintain a rework procedure, to include retesting and reevaluation of the nonconforming product after rework? Read more here: https://t.co/wBnE2JqB21
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#gmptrends #qualityassurance

[GMP TRENDS @GMPTRENDS]

Are you verifying your CAPA Procedures? Developing, maintaining, and implementing your Corrective and Preventive Action Procedures (CAPA) is paramount to your quality systems and the effectiveness of your quality unit.
https://t.co/E1oLlBX08V

[GMP TRENDS @GMPTRENDS]

Quality agreements should cover all aspects of the quality and safety of the product, and must include specifics about any changes in the product’s manufacturing, equipment, or other related processes.
Read More Here: https://t.co/61oTjfRj23

[GMP TRENDS @GMPTRENDS]

The right warehouse management system can help you stay compliant with your acceptance activities, labeling, shipping, storage, quarantining and security.
Stay up to date with U.S. FDA inspection trends and stay in compliance with GMP Trends. --> https://t.co/qTK2DVri0T

[GMP TRENDS @GMPTRENDS]

Be ready for your next #FDA inspection. Our checklist gives the user a description of critical preparatory steps to take in order to be ready for the next inspection. Download for FREE today. https://t.co/T7j2jnHTCr #fda483 #regulatorycompliance #qualityassurance

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Are You Prepared for an Out of Specification (OOS) Investigation? - GMP Trends https://t.co/CFJzldZBnY

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The baby formula shortage could have been avoided with proper building maintenance. More observations related to building maintenance here: https://t.co/TUNM59Ld7R

#fda #gmp #qualityassurance #regulatorycompliance

[GMP TRENDS @GMPTRENDS]

Are you storing your pharmaceutical labels properly? Labels must be stored in a manner to prevent mixups and provide proper identification. A company received the following FDA 483 observation regarding label storage - https://t.co/1hBxDLJWBo

#gmp #fda #pharmaceutical

[GMP TRENDS @GMPTRENDS]

Recently the FDA revised their guidance for procedures for reviewing OOS results in pharmaceutical laboratories. Download the updated document here:
https://t.co/Iux45ViT3L

#gmp #fda #oos #regulatorycompliance #pharmaceutical #qualityassurance

[GMP TRENDS @GMPTRENDS]

Success begins in the planning stages. If your Standard Operating Procedure is well established, then your quality assurance efforts will follow. Download our template as a guide for your comprehensive SOP. https://t.co/qDep6okHJo

#gmp #fda #fda483 #regulatorycompliance #qu ...

[GMP TRENDS @GMPTRENDS]

Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose. Are your analytical methods validated properly? https://t.co/wgyG8CvAcY

#gmp #fda #qualityassurance #regulatorycompliance #fda483

[GMP TRENDS @GMPTRENDS]

Are you ready for your Annual Product Review? Download our free preparation package; templates and checklists to help facilitate your review. https://t.co/MkbrPoueiG

#gmp #fda #fda483 #regulatorycompliance #qualityassurance