Like procedures, protocols, methods, and specifications, documents provide instructions to perform tasks and make decisions safely, effectively, compliantly, and consistently. Records such as batch manufacturing records, cleaning logs and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were made in keeping with procedures and GMP expectations. Reports are yet another […]
Observation 1 Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards The firm inspected lacked accurate raw laboratory data records for batches of API that were shipped. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, Quality Control (QC) […]
Most companies have experienced being audited and, where necessary, “defending” the work carried out in their analytical laboratories during audits. Historically, laboratories have tended to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical equipment, and information about training of their laboratory staff as justification for the […]
The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it […]
On way to manufacturing process end number of steps, tests, check, audits and evaluation is there combined with other quality system elements such as qualification validation and many more. All these impart confidence that the system or process is functioning as intended and assurance of safety, identity strength and quality. The last hurdle is that […]
It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape around every corner. To ensure compliance with regulations, the FDA conducts inspections of all registered establishments. Once the inspection is closed out, it is categorized in […]
The United States Food and Drug Administration (FDA) defines a Warning Letter as “…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be […]
Selection of Glass compatibility with drug product is major issue in Sterile Pharmaceutical practice. Physical and & Chemical stability is the major issue. Wrong selection of glass type caused breakages during Lyophilization, washing, DHS etc activity. “ As per 21CFR211.94 Drug product containers and closures: (a) Drug product containers and closures shall not be reactive, […]
“Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” QUALIFICATION The premises, the supporting utilities, the equipment and the processes have been designed in accordance with the requirements of GMP. This normally constitutes Design Qualification or DQ. Design qualification […]
CFR – Code of Federal Regulations Title 21
