Quality at Apollo

Raw materials

The commodities used are the primary factor in regulation. All active ingredients, excipients, and packaging materials used in our products are sourced from reputable suppliers. In the manufacturer’s quality control laboratory, samples are tested using reliable and scientifically acknowledged procedures.

As part of commodity regulation, the following quality variables are examined:

• Identify – The identity test verifies the correct identification of a pharmaceutical ingredient in a medicinal product. This is crucial to ensure the use of the correct active ingredient in production and prevent any mix-ups.
• Substances – The substance test ensures that the commodity used conforms to predetermined tolerances for the indicated content. This is crucial for the calculation of the original weight of the sample during production.
• Pureness – The purpose of this test is to ensure that the raw materials in use comply with legal purity requirements. They may contain prohibited amounts of synthetic by- products, heavy metals, or organic solvent residuals. Quality is also assured through microbiological purity control.
• Other tests –  Some tests are not required by the pharmacopoeia. These include for example, particle size testing of low water solubility APIs. This is required during drug development to ensure consistent drug release and therefore consistent bioavailability of the finished drug. We also ensure that raw materials are free of nitrosamines.

Our medicines are made exclusively from approved raw materials (e.g. CEP, DMF). These are subject to incoming goods inspection and quality control.

Controlling the process

Continuous in-process controls to maintain all critical parameters are performed and documented during production. These include checks for residual moisture in tablet granules, tablet weight and physical properties of dosage forms. Testing an Active Pharmaceutical Ingredient (API) for making an injectable drug involves several critical steps to ensure safety, purity, potency, and efficacy. Here’s an overview of the process:

• Identification Testing – This initial test confirms the identity of the API to ensure it’s the correct substance. Techniques like Infrared (IR) spectroscopy, Nuclear Magnetic Resonance (NMR) spectroscopy, or Mass Spectrometry (MS) can be used.
• Purity Testing – Impurities in an API can have significant health impacts. High – Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and other chromatographic methods are employed to test for impurities such as organic or inorganic compounds, residual solvents, and degradation products.
• Potency Testing – This ensures the API has the correct strength and concentration. Assays, which can be chemical or biological, are performed to quantify the active substance in the API.
• Sterility Testing – Since the API is for an injectable drug, it must be sterile. This is tested using methods like membrane filtration or direct inoculation to ensure there are no viable microorganisms.
• Endotoxin Testing – Injectable drugs must be free from endotoxins, which are toxins released by bacteria. The Limulus Amebocyte Lysate (LAL) test is a common method used for endotoxin testing.
• Stability Testing – This assesses how the quality of the API changes over time under the influence of environmental factors like temperature, humidity, and light. It’s crucial for determining the shelf life and storage conditions of the drug.
• Particle Size Analysis – For injectables, particle size can impact the safety and efficacy of the drug. Techniques like laser diffraction or dynamic light scattering might be used for this analysis.
• Solubility and pH Testing – The solubility of the API in various solvents and its pH when in solution are important for injectables, influencing factors like drug delivery and compatibility with the body.

Controlling finished products

Every batch produced is subjected to a final check by our producers. This assures that our goods meet the appropriate pharmaceutical quality standards.

Every batch is subjected to the following tests:

• Identity – The identify check ensures that the proper active medicinal ingredients were utilized and that no cross-contamination occurred.
• Active ingredient content – This inspection verifies that the amount of active ingredient in the medicine matches the amount indicated in the dossier, ensuring that patients receive the correct amount of active ingredient.
• Pureness – This test, for example, is used to demonstrate that no active ingredient was swapped during manufacture. In addition, solid dosage forms and solutions are colony counted and inspected for microbiological purity to confirm the absence of harmful germs, yeast, and mold. Injection solutions are checked for sterility and, if necessary, the absence of pyrogens (i.e., free of fever-inducing impurities). Physical inspections. Important features are examined depending on the dose type, such as:
• Tablets and Capsules: Appearance, mass uniformity, hardness (tablets), and dissolve time. The release of active substances is also evaluated because it is an important element in the bioavailability of many medications.
• Solutions for injection: Clarity and color of the solution, pH, density, osmotic concentration, and suspended materials are all factors to consider.
• Injectables: These include solutions, suspensions, or emulsions administered via injection. They are used when a rapid drug response is necessary, or when a drug cannot be taken orally. They can be designed for intravenous, intramuscular, or subcutaneous administration.
• Liquids: Liquid formulations like syrups, elixirs, and suspensions are used for drugs that are not stable in solid form or for patients who have difficulty swallowing tablets or capsules, such as children and the elderly.

Assembly and batch compliance

The finished pharmaceutical product is put in foldable boxes with patient information at the conclusion of the process. Focused in-process inspections ensure that no goods, package inserts, or packaging materials are mixed up.
Analytical testing from raw ingredients to final pharmaceutical medicines ensures that only error-free pharmaceutical products reach the market. Every product must retain the same degree of pharmaceutical quality from batch to batch (batch consistency).