An "SOP Manual for Pharmaceutical Preparation Manufacturing" provides a range of rewards and advantages for the pharmaceutical industry:

Quality Assurance: It ensures standardized processes, leading to consistent product quality, safety, and efficacy, crucial for pharmaceutical companies' reputation and regulatory compliance.
Compliance: The manual helps pharmaceutical manufacturers meet strict regulatory standards, reducing the risk of legal and financial consequences.
Efficiency: Well-documented procedures optimize manufacturing processes, reducing waste, and improving production efficiency, resulting in cost savings.
Safety and Risk Mitigation: Clear safety protocols minimize the risk of accidents and contamination, ensuring the well-being of employees and product integrity.
Training and Onboarding: It facilitates the training of new employees, accelerating their integration into the manufacturing process and reducing errors.
Supply Chain Coordination: Standardized processes aid in coordinating with suppliers, ensuring a consistent flow of raw materials and components.
Research and Development Support: The manual provides a basis for consistent experimentation and testing, aiding in the development of new pharmaceutical products.
Brand Reputation: Consistency and quality, driven by SOPs, enhance the brand's reputation and competitiveness in the pharmaceutical market.

In summary, the "SOP Manual for Pharmaceutical Preparation Manufacturing" is a critical tool for ensuring quality, safety, compliance, and competitiveness in the pharmaceutical industry, benefiting both businesses and patients.

CLICK HERE to download the List of SOPs Document in PDF format. Please share this document with your clients, colleagues and senior officers.

Top 50 Standard Operating Procedures (SOPs) for Pharmaceutical Preparation Manufacturing

SOP-1116-001: Standard Operating Procedure for Pharmaceutical Preparation Manufacturing Overview
SOP-1116-002: Standard Operating Procedure for Quality Control in Pharmaceutical Manufacturing
SOP-1116-003: Standard Operating Procedure for Good Manufacturing Practices (GMP) Compliance
SOP-1116-004: Standard Operating Procedure for Personnel Hygiene and Gowning Procedures
SOP-1116-005: Standard Operating Procedure for Equipment Cleaning and Sterilization
SOP-1116-006: Standard Operating Procedure for Raw Material Storage and Handling
SOP-1116-007: Standard Operating Procedure for Weighing and Dispensing Procedures
SOP-1116-008: Standard Operating Procedure for Granulation Process in Pharmaceutical Manufacturing
SOP-1116-009: Standard Operating Procedure for Mixing and Blending of Pharmaceutical Ingredients
SOP-1116-010: Standard Operating Procedure for Wet Granulation Procedures

SOP-1116-011: Standard Operating Procedure for Tablet Compression and Coating
SOP-1116-012: Standard Operating Procedure for Capsule Filling Procedures
SOP-1116-013: Standard Operating Procedure for Liquid Oral Dosage Form Manufacturing
SOP-1116-014: Standard Operating Procedure for Ointment and Cream Preparation
SOP-1116-015: Standard Operating Procedure for Parenteral Drug Product Manufacturing
SOP-1116-016: Standard Operating Procedure for Sterile Product Filling and Packaging
SOP-1116-017: Standard Operating Procedure for Lyophilization (Freeze Drying) Process
SOP-1116-018: Standard Operating Procedure for Packaging and Labeling of Pharmaceutical Products
SOP-1116-019: Standard Operating Procedure for Batch Record Documentation and Review
SOP-1116-020: Standard Operating Procedure for In-Process Sampling and Testing

SOP-1116-021: Standard Operating Procedure for Stability Testing of Pharmaceutical Products
SOP-1116-022: Standard Operating Procedure for Environmental Monitoring in Manufacturing Areas
SOP-1116-023: Standard Operating Procedure for Handling and Disposal of Hazardous Materials
SOP-1116-024: Standard Operating Procedure for Storage and Distribution of Finished Products
SOP-1116-025: Standard Operating Procedure for Cleaning Validation in Pharmaceutical Manufacturing
SOP-1116-026: Standard Operating Procedure for Change Control and Deviation Management
SOP-1116-027: Standard Operating Procedure for Equipment Qualification and Validation
SOP-1116-028: Standard Operating Procedure for Process Validation in Pharmaceutical Manufacturing
SOP-1116-029: Standard Operating Procedure for Investigation of Out-of-Specification (OOS) Results
SOP-1116-030: Standard Operating Procedure for Handling and Reporting Adverse Events

SOP-1116-031: Standard Operating Procedure for Continuous Process Improvement in Manufacturing
SOP-1116-032: Standard Operating Procedure for Quality Risk Management in Pharmaceutical Manufacturing
SOP-1116-033: Standard Operating Procedure for Training and Competence Development for Manufacturing Personnel
SOP-1116-034: Standard Operating Procedure for Contamination Control in Pharmaceutical Manufacturing
SOP-1116-035: Standard Operating Procedure for Batch Release and Product Certification
SOP-1116-036: Standard Operating Procedure for Recalls and Product Withdrawals
SOP-1116-037: Standard Operating Procedure for Documentation and Recordkeeping Procedures
SOP-1116-038: Standard Operating Procedure for Good Documentation Practices (GDP) in Manufacturing
SOP-1116-039: Standard Operating Procedure for Handling of Reference Standards
and Retention Samples
SOP-1116-040: Standard Operating Procedure for Material and Product Quarantine Procedures

SOP-1116-041: Standard Operating Procedure for Labeling Control in Pharmaceutical Manufacturing
SOP-1116-042: Standard Operating Procedure for Handling of Reprocessing and Reworking
SOP-1116-043: Standard Operating Procedure for Handling of Residual Solvents
SOP-1116-044: Standard Operating Procedure for Process Analytical Technology (PAT) Implementation
SOP-1116-045: Standard Operating Procedure for Monitoring and Calibration of Manufacturing Equipment
SOP-1116-046: Standard Operating Procedure for Handling of Excipients in Pharmaceutical Manufacturing
SOP-1116-047: Standard Operating Procedure for Manufacturing Batch Size Determination
SOP-1116-048: Standard Operating Procedure for Handling of Contaminated and Rejected Batches
SOP-1116-049: Standard Operating Procedure for Cleaning and Maintenance of Manufacturing Areas
SOP-1116-050: Standard Operating Procedure for Continuous Improvement and SOP Review Process in Pharmaceutical Manufacturing

Standard Operating Procedure - SOP ToolBox (1)

SOP ToolBox: If you are reading these lines, I am sure you are looking for Standard Operating Procedure guidelines or SOPs itself. In both the cases, searching in internet will not be yielding any great help. Because no company shares their SOP Development Process and certainly don’t share their SOP Documents. The best way to develop an SOP is creating one for yourself. At Fhyzics, we write SOPs day-in and day-out for companies across the globe including some of the Fortune 500 organisations. Our charge ranges from USD 5000 to USD 50000 depending upon the number of processes to be covered. Certainly, this is not affordable to small and mid-size organisations. Hence, we decided to create this SOP ToolBox to disseminate our 8-Step SOP Development Life-Cycle and best practices at an unbelievably low price.

I always say, writing an SOP is somewhere between art and science. So far you may be clueless on where to start and how to progress on an SOP? This will not be the case after you diligently go through this SOP ToolBox. We have summarised all our secrets here to get you started and to deliver a stunning SOP to your management.

List of products that are being made under this industry

Adrenal medicinal preparations manufacturing
Analgesic preparations manufacturing
Anesthetic preparations manufacturing
Angiourographic diagnostic preparations manufacturing
Antacid preparations manufacturing
Anthelmintic preparations manufacturing
Antibacterial preparations manufacturing
Antibiotic preparations manufacturing
Antidepressant preparations manufacturing
Antihistamine preparations manufacturing
Antineoplastic preparations manufacturing
Antipyretic preparations manufacturing
Antiseptic preparations manufacturing
Antispasmodic preparations manufacturing
Astringent preparations manufacturing
Barbiturate preparations manufacturing
Barium in-vivo diagnostic substances manufacturing
Belladonna preparations manufacturing
Birth control pills manufacturing
Botanical extract preparations (except in-vitro diagnostics) manufacturing
Cardiac preparations manufacturing
Cathartic preparations manufacturing
Central nervous system stimulant preparations manufacturing
Coagulation in-vivo diagnostic substances manufacturing
Cold remedies manufacturing
Contraceptive preparations manufacturing
Contrast media in-vivo diagnostic substances (e.g., iodine, barium) manufacturing
Cough drops, medicated, manufacturing
Cough medicines manufacturing
Cyclopropane medicinal preparations manufacturing
Dermatological preparations manufacturing
Diagnostic biological preparations (except in-vitro) manufacturing
Dietary supplements, compounded, manufacturing
Digestive system preparations manufacturing
Digitalis medicinal preparations manufacturing
Diuretic preparations manufacturing
Effervescent salts manufacturing
Electrolyte in-vivo diagnostic substances manufacturing
Eye and ear preparations manufacturing
Fever remedy preparations manufacturing
Glandular medicinal preparations manufacturing
Hematology in-vivo diagnostic substances manufacturing
Herbal supplements, compounded, manufacturing
Hormone preparations (except in-vitro diagnostics) manufacturing
In-vivo diagnostic substances manufacturing
Insulin preparations manufacturing
Intravenous (IV) solution preparations manufacturing
Iodinated in-vivo diagnostic substances manufacturing
Laxative preparations manufacturing
Lip balms manufacturing
Metabolite in-vivo diagnostic substances manufacturing
Mouthwashes, medicated, manufacturing
Muscle relaxant preparations manufacturing
Nonprescription drug preparations manufacturing
Nuclear medicine (e.g., radioactive isotopes) preparations manufacturing
Oral contraceptive preparations manufacturing
Patent medicine preparations manufacturing
Penicillin preparations manufacturing
Pharmaceutical preparations (e.g., capsules, liniments, ointments, tablets) manufacturing
Pituitary gland preparations manufacturing
Radioactive in-vivo diagnostic substances manufacturing
Sedative preparations manufacturing
Sodium chloride pharmaceutical preparations manufacturing
Sodium salicylate preparations manufacturing
Suppositories manufacturing
Technetium medicinal preparations manufacturing
Thyroid preparations manufacturing
Tincture of iodine preparations manufacturing
Tranquilizer preparations manufacturing
Vermifuge preparations manufacturing
Veterinary medicinal preparations manufacturing
Vitamin preparations manufacturing
Water (i.e., drinking) decontamination or purification tablets manufacturing
Zinc oxide medicinal preparations manufacturing

North America is the largest market for pharmaceutical preparations manufacturing in terms of revenue, followed by Europe. The Asia Pacific region is expected to witness lucrative growth and emerge as the fastest-growing region, owing to the efforts of China to become the world’s second-largest market overtaking Japan. Other emerging economies such as India, South Korea, Malaysia, Indonesia, and Thailand are expected to generate huge sales owing to low cost, amplified medical tourism, healthier lifestyle adoption, higher disposal incomes, and growth of generics. High efficiency and low cost of labor further act as drivers for opening up of manufacturing facilities in the region.

Some of the major players of this industry are

Pfizer
GlaxoSmithKline
Novartis
Amgen
Takeda
Abbott Laboratories
Sanofi
Astra Zeneca
Roche
Eli Lily
Merck & Co.
Novo Nordisk
Gilead Sciences
Lupin
Cipla
Actavis
Otsuka
Bayer
Daiichi Sankyo
Amgen Inc
Boehringer Ingelheim Pharmaceuticals Inc
Johnson And Johnson
Amphastar Pharmaceuticals Inc
Allergan Inc
Teva North America
Astellas US, LLC
P. Purdue Pharma
Upsher smith Laboratorles Inc
Immucor Inc
Vi Jon Laboratories Inc
Endo Health Solutions Inc
Acorda Therapeutics Inc
Assertio Therapeutics Inc
Osmotica Pharmaceuticals plc
Forest Laboratories Inc
Alexion Pharmaceuticals Inc
Noven Pharmaceuticals Inc
Nektar Therapeutics
United Therapeutics Corp
Ultragenyx Pharmaceuticals Inc
PetIQ Inc
Tishcon Corp
Jazz Pharmaceuticals, PLC
Medapointe Pharmaceuticals
Reliv' International Inc
Lannett Co Inc
Aptevo Therapeutics Inc
Acceleron Pharma Inc
Colorado Serum Company
Bausch Health
Supernus Pharmaceuticals Inc
Prestige Brand Holdings Inc
Loxo Oncology Inc
Amicus Therapeutics Inc
XOMA Corp
Bilcare Inc
Paratek Pharmaceuticals Inc
Argos Therapeutics Inc
Cooperative Farmers Elevator
Pfenex Inc
Adamas Pharmaceuticals Inc
Amneal Pharmaceuticals Inc
Solid Biosciences Inc
Neos Therapeutics Inc
Ocular Therapeutix Inc
Ra Pharmaceuticals Inc
Aduro Biotech Inc
American Bio Medica Corp
Chimerix Inc
Synergy Pharmaceuticals Inc
ProPhase Labs Inc
Cumberland Pharmaceuticals Inc
TCP Reliable Inc
Horizon Pharma Inc
Intarcia Therapeutics Inc
Arvinas Holding Company, LLC
Axovant Sciences Inc
Corium International Inc
MyoKardia Inc
Otonomy Inc
Insys Therapeutics Inc
Advanced Cell Technology Inc
Cempra Pharmaceuticals Inc
Quark Pharmaceuticals Inc
Spectrum Pharmaceuticals Inc
Enanta Pharmaceuticals Inc
Heron Therapeutics Inc
United Guardian Inc
Pd Rx Pharmaceuticals Inc
Merrimack Pharmaceuticals Inc
Evolus Inc
Sage Therapeutics Inc
Keryx Biopharmaceuticals Inc
Imprimis Pharmaceuticals Inc
Sunesis Pharmaceuticals Inc
Alimera Sciences Inc
Concert Pharmaceuticals Inc
Vital Therapies Inc
Verastem Inc
Aimmune Therapeutics Inc
Ligand Pharmaceuticals Inc
ContraVir Pharmaceuticals Inc
AVEO Pharmaceuticals Inc
Grifols Inc
DFB Pharmaceuticals Inc
Siegfried USA, LLC
Innovus Pharmaceuticals Inc
MedTest
TG Therapeutics Inc
Exeltis USA Inc
Biodelivery Sciences International
CTI Clinical Trial And Consulting
Anazao Health Corp
Molecular Imaging Chicago
Saretta Therapeutics
Curatech Industries Inc
Catalyst Pharmaceuticals Inc

Some of the challenges faced by this industry are

Reluctance To Adopt New Processes

According to McKinsey’s research, traditional companies like pharmaceuticals have taken their time to fully capture the productivity and opportunity potential of new processes and digitization. Effective execution and management of digital processes can be challenging, but failure to invest in new processes may cause bigger risks. The products the industry makes (and needs coming down the pipeline) are requiring different manufacturing techniques than those of production years ago.

Cleanrooms are a crucial part of pharmaceutical and medical manufacturing. If the cleanroom design doesn't support the new processes and is not up to industry standards, it can cause major inefficiencies. By putting technical and procedural advances together with quality risk-based approaches, many industry leaders are improving process equipment systems, reducing capital and operating costs, and even product cost.

In addition, manual processes and spreadsheets are still prevalent in many pharmaceutical industry processes and this, unfortunately, may lead to guesswork, inaccurate data, and error-prone outcomes. Customer and vendor relationships may be affected and will likely move to competitors.

Pharmaceutical manufacturing companies who have invested in upgraded solutions benefited from better inventory management, solved data challenges, increased workforce productivity, optimized fulfillment processes, and improved customer and vendor experience.

Complex Supply Chains

For years, the manufacturing supply chain has been shifting away from the paper-and-technology model of information management to an all-digital approach, and now automating the supply chain is a shift that has gone from optional to essential. That’s because research shows that companies that embrace digital supply chains boost revenue by more than nine percent, market valuation more than 12 percent, and profitability by over 26 percent.

But for the pharmaceutical industry, their supply chain is highly complex and more regulated than other industries. With multiple suppliers in multiple locations, strong collaborative relationships are necessary to supply chain success. But pharmaceuticals’ complex supply chain is challenged with the need to create end-to-end transparency — and digital transformation aims to bring it all together in one place.

Pharmaceutical manufacturers should shift to technology advancements that not only present a full picture of the supply chain but offer insight into cost savings opportunities and smart inventory solutions.

Governing bodies

Central Drugs Standard Control Organisation (CDSCO) https://cdsco.gov.in/
National Pharmaceutical Pricing Authority (NPPA) http://www.nppaindia.nic.in/en/
The Food and Drug Administration (FDA) https://www.fda.gov/

For further references

The global pharmaceutical preparations manufacturing market is expected to witness lucrative growth over the forecast period, owing to the increasing prevalence of chronic diseases and the growing demand for medications. Major drivers for the market are improved healthcare standards, quick and immediate relief expectations of patients, and the expiry of various patents over the next few years. The discovery of numerous new pathogens and development of medicine to treat/ prevent illness due to the same reason, also contribute to the growth of the market. The availability of health insurance to individuals that help meet healthcare expenses is another high impact rendering driver for this market. Rising awareness for disease prevention rather than treatment contributes to enhancing the growth of the preventive medicine market. Huge investments by the market players and supportive government initiatives into R&D and technological advancement in treatment discovery are expected to fuel the market during the forecast period.

The pharmaceutical preparations manufacturing market is segmented on various bases, such as prescription requirements, end-users, formulation, route of administration, and type of disease. Based on the prescription requirements, the market is classified into prescription-based medicines and OTC (Over the Counter) medicines. Based on end-user they are classified into, neonates and pediatrics, adults, geriatrics, and pregnant women. Presently the market is dominated by the geriatric segment and is expected to remain the same during the forecast period due to the rising base of the global geriatric population. On the basis of formulation, the market is segmented into tablets, capsules, injectables, syrups, suspensions, emulsions, powders, and others. Based on the route of administration, the market is segmented into oral, topical, enteral, parenteral, and inhalations. The market for oral medicines is the largest of the entire segment in terms of production. On the basis of disease, the market is segmented into cardiovascular, neurological, renal, cancer, respiratory disease treatment, and others.

Research By : Mohammed Ijas

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