GMP Requirements in Weighing: What You Need to Know

In pharmaceutical production and quality control testing, weighing products is one of the most critical quality control steps. For this reason, production operators and customers, contract manufacturers and regulatory authorities all focus on this point.

Operations in the pharmaceutical industry are ensured through comprehensive documentation and measurements as well as quality assurance. Binding regulations for this quality assurance and documentation are established by GMP and GLP. For equipment in production or laboratory, these regulations (GMP and GLP) require the operator to document proof of the suitability of the devices used. This encompasses hardware qualification and software validation. According to these standards, for quality-related weighing, GMP and GLP practices require the use of balances designed and developed by balance manufacturers to meet these requirements. Sartorius provides its customers with balances designed functionally and structurally for balance use in regulated areas and meeting the required software and hardware specifications. Sartorius Cubis and Secura balances are scales specially designed for the pharmaceutical industry to fully meet GMP and GLP requirements. Sartorius balances also provide information support, recording the work performed by the user and supporting the quality assurance needs requested by the operator. Additionally, upon request, the company's pharmaceutical-suitable service department can monitor the product through all stages. This begins with the selection of the correct balance with appropriate traceability software and the selection of the appropriate user application. Subsequently, with the purchase of weighing equipment, it continues with the validation of products and user requirements, GAMP classification qualities, as well as internal device applications and customer-specific software applications. At this stage, APC (Advanced Pharmaceutical Compliance) service performs maintenance, calibration, verification, qualification and validation operations and concludes with data backup as well as decommissioning of the weighing equipment. Cubis balances can be directly adapted to customer-specific applications. SOPs (Standard Operating Procedures) used in the pharmaceutical sector can be fully integrated with the balance. If the customer wishes to perform a complex application, scale integration with validated and documented customer- or application-specific software can be provided. For example, the MSA125P-100-DI can be used in areas such as the pharmaceutical sector with an automatic enclosure and built-in ion removal system. The MSA125P-100-DI balance is designed for use in pharmaceutical laboratories and clean rooms in production areas. It has modular features to operate under different environmental conditions. Different units such as control screen, enclosure and weighing module are selected by the user, allowing the balance to be application-specific for the customer. The surface of the laboratory balance is designed in accordance with hygiene and cleaning requirements and is compliant with EU GMP (European Good Manufacturing Practice) for use in clean rooms. An internal ion removal unit and automatic enclosure have been developed to eliminate the effect of static electricity on weighing, and to reduce measurement uncertainty and provide high repeatability. The suitability of the balance for pharmaceutical products is determined by its feature of providing the correct measurement range and required accuracy according to EU GMP. According to USP Chapter 41, the optimal measurement range is from 820 d to maximum capacity. Depending on the specific application, the balance provides the requirements requested by the user. Equipment used in API testing or production must be qualified. The requirements for qualification are specified in Annex 15 of the EU guideline for GMP. Sartorius provides qualification documents (risk analysis, DQ/IQ/OQ) to its users. The software within Cubis balances has been proven to help reduce the risk of incorrect weighing. The user management system helps eliminate application errors. In addition, the data transfer system provides secure two-way data transmission with LIMS (Laboratory Information Management System) or other software. Cubis stores user data in its memory and records any changes made. Thus, it enables retrospective traceability of weighing data and ensures data security. To prevent contamination of samples or weighed objects, all components of the balance meet GMP and GLP requirements. All surfaces are easily cleaned and resistant to cleaning agents. The weighing pan and enclosure can be easily removed and cleaned. In independent research services, it has been proven that cleaning of lipophilic and hydrophilic substances is possible at all critical points of the balance.   Mustafa Yetim Sales Manager Sartonet Separation Technologies Inc.