Best Practices for Global GMP and CMC:
A Multilingual Approach
Quality is always top of mind when it comes to manufacturing drug products for the global life sciences industry. This holds true both on the production floor and in the realm of documentation. In order to ensure that drug products meet uniformly high standards of quality, consistency, and safety, the industry adheres to two sets of comprehensive guidelines for quality control in the development and manufacturing of drugs, cosmetics, combination products, and medical devices: Good Manufacturing Practices (GMP) and Chemistry, Manufacturing, and Controls (CMC).
These standards require compliance with regulations and guidelines set out by regulatory authorities such as the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA). They require careful documentation, validation, and control of processes and procedures. Hygiene requirements and personnel training standards must also be met. Regulatory affairs experts know that accurate translation is not only essential to ensuring that these standards are consistently applied across a global supply chain but also serves as a key driver of business growth. How? Let’s dive in.
The Relationship Between CMC and GMP
CMC and GMP are similarly stringent frameworks for the pharmaceutical industry. However, they differ in terms of scope and focus and apply to different phases of pharmaceutical product manufacturing and development.
What is CMC?
CMC stands for Chemistry, Manufacturing, and Controls, which refers to the various methods of assessing the chemical and physical properties of drug products.
They are the cornerstones of drug development and intended to safeguard uniformly high-quality standards and product specifications throughout the development and manufacturing of pharmaceutical products. CMC is in place to ensure drug products are safe, effective, and consistent in terms of formulation, stability, and release. Compliance with CMC is an integral, required part of the drug approval process.
Typical documents include Investigational New Drug (IND) applications, New Drug Applications (NDA), Marketing Authorization Applications (MAA), and Common Technical Documents (CTD).
What is GMP?
The name (almost) says it all: Good Manufacturing Practices set the standard for the production of safe, effective pharmaceutical products of the highest quality. Pharmaceutical companies are mandated to comply with GMP and audited for compliance on a regular basis.
While these quality assurance principles primarily focus on manufacturing, they also include guidelines for hygiene, equipment maintenance, and training. The main components of GMP are commonly referred to as the “5Ps”: People, Products, Processes, Procedures, and Premises.
Typical documents include Standard Operating Procedures (SOP), Batch Production Records (BPR), Site Master Files (SMF), Quality Manuals, Validation Master Plans (VMP), Product Quality Reviews (PQR), validation protocols, and reports.
More recently, the FDA implemented cGMP, an acronym that stands for current Good Manufacturing Practices. This framework goes one step further by focusing on continuous improvement, assuring that manufacturers are using the most up-to-date technologies, systems and practices.
Translation of GMP and CMC Documents
Regulations on which documents must be translated for compliance vary widely across countries and regions. Each agency has unique requirements. In the realm of manufacturing, as well as patient- and provider-facing content, all content must generally be made available in a language and at a level that the intended audience understands.
As a rule, product information documents (e.g., Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling and packaging information), as well as documents for regulatory submissions (e.g., Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA)), are first in line for translation. In addition, various GMP and CMC documents are usually translated into the languages of different locales, such as Standard Operating Procedures (SOP), quality control documents, and validation protocols.
In a world where drug development and manufacturing can be spread across multiple countries, and different approval processes apply, this is only logical: Comprehension is arguably the first and most important step of quality control and safety.
How Translation Drives Business Growth in GMP and CMC
Achieving regulatory compliance across global markets requires precise translation of GMP and CMC documentation, including regulatory filings, quality control protocols, and standard operating procedures. Accurate, high-quality translations help companies confidently expand their international operations by reducing legal risks, avoiding non-compliance penalties, streamlining approval processes in new markets, and ensuring adherence to quality standards.
Translating manufacturing and quality control (QC) into local languages improves operational efficiency by reducing the risk of errors, enhancing productivity, and facilitating the sharing of knowledge. This enables companies to optimize processes, reduce costs, and achieve higher production quality.
Through the accurate translation of user manuals, product labels, and safety protocols, companies can further reduce the risk of accidents, minimize operational errors, and ensure the effective, safe use of their products. This, in turn, protects their reputation and allows them to prioritize safety, build consumer trust and reduce liability risks. Supply chain management also benefits from effective localization in the form of better quality control, streamlined logistics and procurement, as well as smoother interaction with global business partners and suppliers.
Labeling Documents
To ensure that pharmaceutical product information is standardized across different countries and regions, various labeling documents such as Company Core Data Sheets (CCDS) and Core Safety Information (CSI) are the foundation for worldwide product labeling. In global labeling, translation is crucial in ensuring that key safety, efficacy, and usage information is accurately conveyed to healthcare providers and patients in their language.
Finally, precise, high-quality localization drives innovation and collaboration by facilitating not only the sharing of expertise among global R&D teams but also collaboration with contract manufacturers and international research partners. This has the potential to accelerate innovation and product development.
Life Sciences Translation and Localization: What Matters
GMP/cGMP and CMC are vital standards that ensure the safety, quality, effectiveness, and consistency of medical products. They also protect companies against legal liabilities and loss of trust. In this context, errors can be costly in many ways. Life sciences translation and localization require much more than simply knowing two languages. Providers must be subject matter experts who are well versed in nuances of language and culture, master terminology of the field, and be culturally attuned to practices in both the source and the target locale and language. Working with a trusted partner with industry expertise to achieve reliable, precise, and accurate translations helps avoid such errors and their – potentially devastating – consequences.
Would you like to discuss this with Vistatec’s life sciences experts? Contact us today.