Production – Standard Operating Procedures

A standard operating procedure (SOP) is a written instruction describing how a routine task is to be carried out; when, where and by whom. SOPs play a fundamental role in continuous quality assurance and ensuring best practice for your company, in order to assist you in protecting the safety of your patients and members of the public. The implementation of SOPs, which are specific to your production facility, will help you to:

• ensure quality and consistency of products to pharmacists and to patients
• ensure good practice is achieved at all times
• utilise the expertise of all personnel effectively
• facilitate delegation of appropriate tasks to trained members of staff
• provide role clarification for all members of staff
• provide staff training
• provide assurance of staff understanding of processes to be followed in all areas of the facility, especially the production area
• facilitate communication and team work

The following is a list of equipment and operations that are part of an everyday pharmaceutical manufacturing operation and that require SOPs. Many more could be written and ultimately what is required depends on the location, legal jurisdiction, and nature of the production, equipment used and work performed by staff. The following is therefore a guide to what SOPs are required by a pharmaceutical manufacturing company. The local regulatory bodies and international standards organizations should also be consulted when compiling a list of SOPs for your facility.

• Action to be taken during spillage/breakage of materials
• Action to be taken for unusual observation for instruments during calibration
• Air dryers and air samplers
• Allocating document protocol numbers for instrument calibration/qualification
• Allocating nstrument idenfication numbers
• Area Cleaning Procedure for Processing Areas
• Analysis and release of finished product
• Analysis of water
• Analyst validation
• Analysis Container, accessories, materials, hosepipes
• Antimicrobial Effectiveness testing
• Autocota Cleaning and Operation
• Backp/restore analytical data in electronic form
• Bacterial endotoxin test
• Batch printing machine
• Blister pack machine
• Breakdown, maintenance of equipment, machinery and facility
• Bursting strength tester
• Cad mill
• Cage blender
• Calibration and cleaning of instruments: e.g., UV cabinet, total organic carbon analyser, Autotitrator, Atomic Absorption spectrophotometer, Balance, Brook field viscometer, Bursting strength tester, Colony counter, conductivity meter, conductivity TDS meter, Coulter counter, Disintegration test apparatus, FT-IR, Gas Chromatograph, Glassware, Halogen Moisture Analyzer, HPLC, Hardness tester, HPLC, hot air oven, IR moisture balance, IIR spectrometer, Karl Fischer Apparatus, Melting point apparatus, Microscopes, Ovens, Pipettes and other glassware used in quality control, Polarimeter, Refractometer, UV-Vis spectrophotometer, Vacuum oven, pH meter, TOC analyzer.
• Careful handling of poisonous chemicals
• Checking effectiveness of disinfection/cleaning procedures
• Cleaning procedures for balances
• Cleaning and maintenance of microscopes, boilers, foggers, anaerobic culture jars, microbiological laboratory, autoclave, autodiluter, automatic coating system, automatic cartooning machine, bins and HDPE containers, blister packing machine, box compression strength tester, Cd mill, capsule filling line, centrifuge, chilled water system, clean (sterile) area, colloidal mill, colony counter, conveyors, coulter counter, deburring and dedusting machine, dehumidifier, deep freeze, deblistering machine, dispensing and sampling room, dissolution tester, drum mixer/coater, exhaust ducts, fluid bed dryer, incubators, lighting and electrical fixtures, octagonal blender, ovens, paste kettle, pressure vessel, peristaltic pumps, spraying guns, Quality control laboratory, rapid mixer granulator, refrigerator(s), stainless steel bins – containers - transfer equipment - vessels and equipment, sampling equipment, tablet compression machine, tablet counter, tablet hardness tester, vacuum cleaner, vaccum oven, capsule filling machine, co-mill.
• Inspection of sieves and screens Inspection
• Cleaning and operation of e.g., Vibratory Sifter, Committing Mill Cleaning and Operation, Saizoner Mixer Granulator, Material Transfer System, Co-mill Cleaning, Fluid Bed Dryer/Processor, Tippler, Cage Blender, Centrifuge, Carton sealing machine, Paste Preparation Vessel, Roll Compactor , Tablet Compression Machine, Digital Weighing Balance, Af-90T Automatic Capsule Filling machine, Spray Coating Unit, Blister Packing Machine Cleaning and Operation, Strip Sealing Machine, Blister Defoiler Machine, Packaging lines, Shrink Packaging Machine, Vertopack Cartonator Machine, Packing Conveyor Belt, Colloid Mill Cleaning and Operation, Metal Detector , Euro Clean WD Vacuum Cleaner
• Essae Teraoka Performance Check/ DS-415 Weighing Balance mounted on Pallet Truck
• Materials collected from the debarring machine
• Transfer of lubricated granules from the bunker to the compression machine
• Procurement, inspection and cleaning and uses of punch and dies
• Reprocessing
• Preparation and Use of Lacquer solution Cleaning and Operation
• Cleaning and Operation
• Tablet Inspection Belt Cleaning and Usage
• Guidelines for Packaging Operation
• Excess Packing Material Returns
• Disposal of contaminated material, waste material, expired chemicals, reagents, solvents, and microbiological media
• Disposal of excess packaging materials
• Entry and exit areas – procedures for staff and visitors
• Gowning procedures
• Washing procedures
• Laundry
• Handling and testing of various samples
• Housekeeping
• Inventory and issue of media and materials
• Batch monitoring and BMR
• Environmental monitoring
• Leak Seal and Pinhole Test – For Strips and Blisters
• Rubber Stereos for Coding, Batching Printing Procurement and Handling
• Packing Waste Destruction (During Packing Operation
• Sealing Rollers and Plates Preservation and Cleaning
• Tablet Inspection – Use of Inspection Tray
• Clearance and Cleaning of Lines and Production area
• Digital Weighing Balance ESSAE Calibration
• Systems Plus Blister Collator Machine
• Offline Packing Process
• In-Process Checking
• Repacking