Pharma Definition/Abbreviation, Pharma Beginners
Difference between instrument & equipment
Instrument: is a more specific device used for precise measurement or analysis. Device takes a physical measurement and displays a value. (HPLC,FTIR,pH Meter)
Equipment: is a broad term for a set of tools or machines used to carry out particular process or activity. Assembled to perform a mechanical process. (FBD, RMG, Blender).
Environmental monitoring (EM) in pharma is a documented program for regularly monitoring the manufacturing environment to ensure product quality and patient safety. It involves routinely sampling air, surfaces, and personnel to detect microbial and particulate contamination in controlled spaces like cleanrooms.
Residual solvents are volatile organic chemicals that are used or produced during the manufacturing of pharmaceuticals, food, or other products but are not completely removed. They are classified into three classes (Class 1, 2, and 3) based on their toxicity.
Polar solvents have uneven electron distribution, leading to partial charges and a dipole moment, while nonpolar solvents have an even electron distribution and no dipole moment.
| Name of the Culture | Strain Number |
| ATCC/NCTC
No. |
|
| Escherichia coli | ATCC 8739 |
| Staphylococcus aureus | ATCC 6538 |
| Bacillus subtilis | ATCC 6633 |
| Pseudomonas aeruginosa | ATCC 9027 |
| Salmonella abony | NCTC 6017 |
| Candida albicans | ATCC 10231 |
| Aspergillus niger | ATCC 16404 |
| Clostridium sporogenes | ATCC 11437 |
| Shigella boydii | ATCC 8700 |
6M Process ControlIn quality/process improvement (like Lean/Six Sigma), the 6Ms often mean Man/People, Machines, Materials, Methods, Measurement, and Mother Nature (Environment), used in fishbone diagrams to find root causes of problems by exploring these categories systematically. This framework ensures all aspects affecting a process—from human error to environmental impact—are considered for effective problem-solving and continuous improvement
6M Checklist for Process Control
6M for Manufacturing Success
6M Fishbone Diagram for RCA (Root Cause Analysis)
Bottleneck Analysis/SMART Goals/Heijunka/Hoshin Kanri
Manufacturing Cycle Time (MCT), Manufacturing Cycle Efficiency (MCE), production time, process time, lead time.
