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With its worldwide reach, the ICH’s guidelines for pharmaceuticals are extensive, encompassing four categories: quality; safety; efficacy; multi-disciplinary handling. 

While it’s essential to review each of these sectors, there are a few guidelines to emphasize, including:

ICH Guidelines for Pharmaceuticals

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A significant influencer in the pharmaceutical industry is stability. Without a stable environment, medicines undergo changes that can affect their safety and efficacy, which is why it’s essential businesses understand how environmental factors such as temperature, light and humidity can impact a medication’s shelf life and influence its ideal storage conditions. Guideline Q1A(R2) provides pharmaceutical companies with a stability data package, detailing the following:
<ul>
 	<li>Test type</li>
 	<li>Test frequency</li>
 	<li>Test conditions</li>
 	<li>Test parameters</li>
</ul>
Using your results, you can develop accurate and appropriate labels for your drug products and substances.

Q1A(R2): Stability Testing of New Drug Substances and Products

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While similar to Q1A(R2), this ICH guideline addresses stability testing for biological or biotechnological products — medications with active components that are either proteins or polypeptides. Due to their makeup, these items tend to be more sensitive to environmental conditions, which influences their recommended storage conditions. Per Q5C, pharmaceutical companies should test and analyze the following product factors:
<ul>
 	<li>Color</li>
 	<li>Texture</li>
 	<li>Dissolution time</li>
 	<li>Purity</li>
</ul>
If involved with biological or biotechnological products, it’s essential to examine how the medication interacts with its container and that container’s closure features. Some products, for example, may be delivered via a single-use or multiple-dose vial based on these results.

Q5C: Stability Testing of Biotechnological or Biological Products

When developing this guideline, the ICH wanted to provide the pharmaceutical industry with a universal set of specifications, which include tests, analytical procedures and acceptance criteria. Via Q6A, the ICH hopes to enhance quality assurance and production consistency among pharmaceutical companies. Specifications vary between the following types of medicines:
<ul>
 	<li>Drug substances</li>
 	<li>Drug products</li>
 	<li>Oral liquids</li>
 	<li>Parenteral drug products</li>
</ul>
For example, drug substances should undergo testing to determine their disintegration time while the dissolution time of oral liquids should undergo assessment. Depending on your company’s product, some of the recommended tests may not be applicable. To help determine which ones are, the ICH provides several decision trees.

Q6A: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products

Like Q5C, the Q6B guideline is for biological or biotechnological products. Instead of stability tests, Q6B focuses on specifications for biotechnological or biological medicines, which makes it similar to Q6A. It includes decision trees as well. Due to biological and biotechnological product variances, you should set your specifications based on the following:
<ul>
 	<li>Physiochemical properties</li>
 	<li>Biological activity</li>
 	<li>Immunochemical properties</li>
 	<li>Purity</li>
 	<li>Impurities</li>
 	<li>Quantity</li>
</ul>
After considering these factors, you can determine which tests to conduct, such as those for potency and identity. It’s essential to note that specifications focus on confirming the quality of your batches versus building their characterization.

The reason the above ICH guidelines — Q1A(R2), Q5C, Q6A and Q6B — are often cited is due to their influence on the cold-supply-chain processes within the pharmaceutical industry. An appropriate and accurate assessment of your products provides your in-house team, as well as shippers and distributors, with critical information about how to ship and store your medications.

Q6B: Test Procedures and Acceptance Criteria for Biotechnological or Biological Products

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The FDA and the Pharmaceutical Industry

FDA Guidelines for Pharmaceuticals

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21 CFR Part 203.32: Drug Sample Storage and Handling Requirements

21 CFR Part 203.36: Fulfillment Houses, Shipping and Mailing Services, Co-marketing Agreements and Third-Party Recordkeeping

21 CFR Part 211.142: Warehousing Procedures

21 CFR Part 211.150: Distribution Procedures

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Record

Review

Respond

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Store

Manufacture

Transport

Research

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At Dickson, we’ve become a trusted partner of the pharmaceutical industry. Our innovative software and data loggers for the pharmaceutical industry deliver smart solutions to constant challenges in the sector. From complying with evolving regulations to collaborating with supply-chain links to ensure product quality, our monitoring solutions provide the data, convenience and simplicity you need.

Good practice quality guidelines & regulations: pharma industry