Quality and responsibility towards all those who use our products and services is a fundamental component of our corporate strategy. We thereby take account of the great significance of quality in product safety in the health care market. Overall we align the quality policy throughout the Group to meet criteria that at least fulfill the strict legal requirements for pharmaceutical and health care products.
Assessing the risks of newly arising, previously unknown side effects of active ingredients also plays an important role in the quality of pharmaceutical products. This risk remains low for most of our products as only long-standing and researched active pharmaceutical ingredients are generally used. Of course, we have nevertheless implemented within our operations all the standard graduated plan proceedings for recording or detecting such pharmaceutical product risks throughout the Group.
The most important initial controlling starts with the commodities used.
All of the active pharmaceutical ingredients and auxiliary materials used in the production of our products are procured from prestigious commodities suppliers. Samples are tested according to valid and scientifically recognized test methods in the quality control laboratory of the manufacturer.
The following factors of quality are checked as part of commodity controlling:
The identity test ensures the correct identity of a pharmaceutical ingredient in a pharmaceutical product. It is important for the use of the correct active ingredient in production and to avoid any mix up.
The content test ensures that the commodity used conforms to determined tolerances of the indicated content. This is important for the calculation of the original sample weight in production.
This test ensures that the commodities used conform to legal requirements for purity. For example, they may not contain prohibited amounts of by-products of synthesis, heavy metals or organic solvent residue. Microbiological purity controlling also ensures quality.
- Additional tests
Certain tests that are not prescribed by pharmacopoeia are, in part, necessary. These, for example, include testing the particle size of active ingredients with low water solubility. This is specified in the development of the pharmaceutical product and ensures the constant release of active ingredients and therefore the constant bioavailabity of the finished pharmaceutical product.
We only make use of commodities that have been approved following inspections of incoming goods and quality controls for the production of our pharmaceutical products.
In Process Control
During production, continuous in-process controlling is carried out and documented in order to maintain all the parameters that are important for production. These include the testing of the residual moisture of tablet granules, the tablet weight and the physical properties of dosage forms, etc.
Control Finished Drugs
Every batch produced undergoes an extensive final inspection. This ensures that our products achieve the necessary level of pharmaceutical quality.
Every batch is tested for the following:
The identity inspection serves to confirm the correct active pharmaceutical ingredients were used and that there was no cross-contamination.
- Active ingredient content
This inspection documents whether the amount of the active ingredient in the medicine matches the amount declared which ensures that the patients receive the intended amount of the active substance.
The purity test serves, for example, to prove that no active ingredient was substituted during production. Furthermore, solid dosage forms, ointments and solutions are tested for microbiological purity via colony counting and inspections to ensure the absence of pathogenic germs, yeast and mold. Solutions for injection are inspected for sterility and, if necessary, for the absence of pyrogens (i.e. free of fever-inducing impurities).
- Physical inspections
Depending on the dosage form, important physical properties are checked, such as for:
- Tablets, capsules
Appearance, uniformity of the mass, hardness (tablets), dissolve time. The release of active ingredients is also tested because the release of the active ingredient is a decisive factor in the bioavailability of many medicines.
- Ointments, gels
Appearance, homogeneous dispersion of the active ingredient, viscosity, pH.
- Solutions for injection
Clarity and color of the solution, pH, density, osmotic concentration, suspended solids. Finished pharmaceutical product controlling
Assembly and Batch Conformity
At the end of the process, the finished pharmaceutical product is packaged in collapsible boxes with user information for patients. Targeted in-process reviews ensure that there are no mix-ups of products, package inserts or packaging materials.
Analytical testing starting with raw materials all the way through to the finished pharmaceutical product guarantees that only error-free pharmaceutical products will reach the market. It is crucial that every product maintains the same level of pharmaceutical quality from batch to batch (batch conformity).
EU Falsified Medicines Directive
Introduction of safety features for prescription medicines
As of February 9, 2019, medicinal products for human use subject to prescription laid down in the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 shall bear obligatory safety features.
What is the Falsified Medicines Directive?
The Falsified Medicines Directive is intended to improve the protection of patients from counterfeit drugs in the legal supply chain, thus increasing drug safety. Despite strict controls, there were repeated cases of counterfeit medicines, which had been put into circulation.
Medicines become unique
The safety features consist of two elements placed on the packaging of corresponding STADA products, as follows:
(1) a unique identifier carried by a two-dimensional barcode
The unique identifier in the form of a 2D barcode allows the authentication of a drug as well as identification of individual packages. Visually comparable to a QR code, the following information can be read out in the pharmacy using a scanner (Figure 1):
• product code
• batch number
• expiry date
• unique random serial number
• national reimbursement number, optional
This data must also be printed on the packaging in plain text. In addition, further information can be stored in the data matrix code, such as the dosage form or certain information for billing.
(2) a device allowing the verification of whether the packaging of the medicinal product has been tampered with.
All affected drug packages have to be equipped with a tamper evidence that can be, for example, adhesive or label seals that make a previous opening or manipulation recognizable.
Figure 1: Sample package of a medicinal product with data elements (source: STADA)
The most important questions & answers on the new False Medicines Directive (FMD) at a glance
What are counterfeit medicines?
According to the World Health Organization (WHO), counterfeit medicines are products that contain no active ingredient, the wrong active ingredient or the wrong amount of the right active ingredient.
When do medicines have to be checked for authenticity?
The EU False Medicines Directive will apply as of February, 9 2019. By this date, prescription drugs must carry the new security features and may only be sold to the customer after authentication in the pharmacy.
What are the additional security features on a pharmaceutical package?
Almost every prescription medicine must be provided with two security features by the manufacturer:
- Unique identifier feature in the form of a 2D barcode that makes individual packages identifiable.
- Anti-tampering device that can be used to identify whether the packaging has been tampered with.
How do the security features get onto the packaging?
The drugs affected by the guideline receive the safety features on the packaging from the manufacturer, e.g. from STADA. After that, the data is uploaded into an EU database system (EU hub) and National Verification Systems (NVS) in all participating countries. Before a pharmacy delivers a corresponding product to a patient, the security features have to be checked.
How does the pharmacy check medicines for authenticity?
The pharmacy checks the additional security features. The initial opening protection must be intact. For verification purposes, the data matrix code is also scanned and matched with the National Verification System. If this comparison confirms the authenticity of the drug, the drug can be "checked out" and delivered to the customer. At the same time, the unique serial number is marked as dispensed in the database. If a medicine with the same or an unregistered serial number appears in any pharmacy and is scanned, the system warns as a potential falsification.
Which medicines are affected by the False Medicines Directive?
A few exceptions are the products listed in the “white list” (e.g. homeopathic medicines, radionuclides). In addition, over-the-counter medicinal products on the "black list" (omeprazole in two active strengths) are subject to verification. Drug packages that were put on the market before 9 February 2019 and do not bear any safety features may be handed in until the expiry date.
The verification of a medicinal product in the pharmacy is negative and the medicinal product may not be delivered. Is it a counterfeit?
Particularly in the initial phase, technical problems cannot be ruled out which could also affect the supply of medicines. For example, a handling error with the scanner can inadvertently trigger an alarm. This can also occur if the data did not reach the database due to a technical fault. If a handling error can be ruled out, a possible suspicion of counterfeiting must be investigated in the pharmacy. If the unreleased product is only available in small quantities, a supply shortage could occur.
A drug requiring verification does not have a data matrix code or a serial number?
It is presumably a pharmaceutical package that was released for sale before 9 February 2019 and may be delivered by the pharmacy until the expiry date.
Can a medicine be sold without prior verification if, for example, the internet or electricity fails?
In the event of temporary technical malfunctions, the drug may be delivered and verified and deregistered afterwards. For this purpose, the serial number and the product code must be noted or photographed on delivery.
Who or what does SecurPharm describe?
SecurPharm e.V. is an organization in Germany consisting of associations of pharmaceutical companies, wholesalers and pharmacists who have joined forces to implement the Counterfeiting Directive. The initiative has developed a national system for real-time testing of drugs that has been tested in practice since 2013 and ensures a smooth transition to "live operation".