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In its simplest form, GxPs are like your own SOPs (standard operating procedure); only GxPs are “good practice” guidelines, which are industry governed. A highly regulated pharmaceutical industry must adhere to the specific manufacturing, storage, and distribution processes. The purpose of the regulations is to ensure bio/pharmaceutical products are safe and meet their intended use. The main good practices within the pharmaceutical industry are organized by manufacturing, distribution, clinical, laboratory, and documentation.

01 The 5 "x's" in Pharmaceuticals

”GxP” is an abbreviated term for ”good practice,” but what do the “x's” in the middle mean? They stipulate the particular discipline or field (i.e., good – x – practice). And in the world of pharmaceuticals, that could refer to either:

  1. Manufacturing (GMP)
  2. Distribution (GDP)
  3. Laboratory (GLP)
  4. Clinical (GCP)
  5. Documentation (GDP)

Like any heavily regulated industry, and especially pharma, GxP is essential to how businesses operate. They exist so that medicinal products that reach customers are guaranteed to be safe for human consumption. These strict quality standards, systems, and system management are kept in check through evidence, validation, and audits. The consequences for non-compliance range from damage to your reputation and consumer confidence to more severe issues like product recalls and criminal prosecution. The message for GxP for beginners is: follow them, and follow them well.

GxP for Beginners

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02 GxP Documentation and Computerized Systems Requirements

There's a well-known and often parroted saying in our industry, "if it ain't documented, then it didn't happen." Wise words, and as for GxP basics are concerned – paramount. The length and breadth of boxes you need to tick to get your product produced, packaged, shipped, and delivered are vast. One of the biggest headaches for pharmaceutical businesses is the recording and storage of documentation. Because what information you retain, how it is kept and then stored, all has to be compliant.

In the end, it all comes down to the accessibility and agility of your digital tools. You need to be able to access your products' data down to the batch. This is so you can prove your implementation and observation of GxPs throughout your entire process, assuring the U.S. Food & Drug Administration (FDA) and/or European Medicines Agency (EMA) your products’ quality meets their GxP requirements and are completely safe and secure from tamper.

What documents are required in GxP?

The specific “x” documentation will vary between industries. However, they must confirm the integrity, safety, and quality of your products and services. The shape these documents take is in the form of policies. These policies are then accounted for and actioned as processes or procedures. Examples could include, but aren't limited to:

  • Validation protocols and reports

  • Risk assessments

  • Technical reports

  • Investigations

  • Change requests

Basically, any GxP requirement needs documented approval or validation before moving on to the following process.

Compliant Documentation

It isn't so much the collecting and storing of data that needs to be compliant. It's more the integrity of your document management. These areas are under intense scrutiny by regulatory inspections and are a critical issue in document governance. Regulators now expect staff working in GxP roles to have sufficient data integrity training. GxP for beginners can be tricky to get your head around. Still, compliance for documentation in computerized systems is a whole other ball game, so here it goes…

Your data's integrity includes the maintenance of and assurance of your data's accuracy and consistency. In the eyes of GxP, requirements are seen as the critical component in proving the safety, efficacy, and quality of your product. Violations relating to document management and data integrity are serious and can result in costly repercussions.

GxP Requirements for Computerized Systems – a Checklist

Listing all the documents GxP could require would be exorbitant. Each industry has their individual criteria to administer, but there are some core, standard GxP requirements that could benefit all industries. If you answer yes to each question, you know your foundation is pretty solid and can take industry-specific requirements in stride.

1. Is there a documented process of procedures for:

  • 1(a). the storage, review, maintenance, retention, and archiving of data and documentation;

  • 1(b). guaranteeing the security and controlled access of all business data and documentation;

  • 1(c). deviations from standard procedures;

  • and 1(d). corrective and preventative actions (CAPA)?

2. Is there a back-up system for documents?

3. Are changes to documents audit-trailed replaced with superseded versions and stored?

4. Is there a process of procedures for:

  • 4(a). continuously validating and qualifying the equipment documenting time, date, and relevant personnel;

  • 4(b). establishing agreed and standardized tolerance limits for equipment and asset health;

  • 4(c). replacing equipment or assets whose health falls outside the agreed tolerance limits;

  • 4(d). implementing a continuity plan in the event of IT disruption;

  • and 4(e). documenting changes, maintenance actions, errors, and repairs?

5. Is there a central equipment and asset inventory, including instruction and operation manuals?

Documentation and Computerized Systems Regulations

All you need to know about Documentation and Computerized Systems Regulations when it comes to being GxP cmpliant

03 Process Implementation: GxP Environmental Monitoring

The strength of good GxP isn't in the policies. It's the process implementation into your business operations. When you are learning the GxP basics regarding environmental monitoring, two of the major elements of the process are:

  • Qualification

  • Validation

Qualification According to GxP

In the absence of quality, your product will not make it to the shelves. Quality needs to be assessed in every step of the process in order to get an accurate determination of a product’s safety and efficacy. Qualification is proof that all equipment, systems, and ancillary items are installed properly and working for its intended use.

So, when it comes to controlled environments, it's simple. Your facilities, your areas, your containers need to be up to scratch. They need to be explicitly designed to maintain product quality. This is the reason why humidity and temperature are so keenly mapped. What's mapping? Well, mapping is an exercise that analyzes the temperature and/or humidity distribution within an area.

Validation According to GxP

Validation specifies what deliverables are needed. That means what should be tested, the number of tests, how those tests should be conducted, and how they should be documented. This is the resounding evidence that your products meet the very highest production, storage, and delivery standards.

Temperature Mapping is a Part of Qualification

 

Mapping can demonstrate and document that your chosen storage area is appropriate for storing temperature-sensitive products like medicines and drugs. Mapping will identify the warmest and coldest areas that must be considered and addressed before operation implementation, proving that the temperatures throughout the facility or container are consistent with the required specifications necessary for qualification. Mapping is a test that is required as part of the qualification process.

Validation, Qualification and Mapping

Your starting your GxP process and are looking for some insights on Validation, Qualification and Mapping? We got you covered!

04 The Importance of Calibration Within GxP Regulations

GxP for beginners should know that any company that researches, produces, stores, transports, or sells any pharmaceutical goods are responsible for following regulatory GxP requirements.

Along with mapping, a series of stability testing processes and temperature monitoring throughout production, storage, and distribution are required to ensure the drug meets the standard level of identity, strength, quality, and purity. To pass inspections, equipment and instruments must be monitored by a GxP-compliant monitoring system. A GxP-compliant monitoring system includes sensors that are calibrated correctly and then regularly checked for accuracy. Calibration testing is included in the validation process, and the calibration proves the equipment (sensors) are working as intended.Calibration has to be performed by the approved procedures set by GMP. The records of these calibrations must be retained for auditing purposes over time.

What Exactly is a Calibration?

Calibration is comparing sensors to a traceable reference standard. However, calibration also can prove that instruments and their corresponding monitoring software are aligned. For example, the serial number on the calibrated sensor matches the serial number in the software.

Where are the GxP Regulations for Calibration defined?

CFR Title 21 and/or EU Good Manufacturing Practice (GMP) Guidelines, Volume 4 addresses manufacturing. 21 CFR 11 and Annex 11 references computerized systems and documentation. A technical reference is a computerized calibration system specific to pharmaceuticals. Its aim is to provide automated documentation with less room for human error, improving the overall quality of work and improved efficiencies that can make an impact on profit.

To Conclude

There's no getting away from it. If you're in the business of producing, storing, or transporting pharmaceutical products, you have to comply with GxP guidelines from beginning to end.

Your specifications will identify the needs for your quality system. Your system includes temperature monitoring, where all equipment and associated systems need to be qualified and validated. Qualification and validation requires calibration and mapping.

Happy GxP'ing.

Temperature Sensor Calibration

Find out more about the GxP Guidelines for Temperature Sensor Calibration.

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