Weighing and Dispensing in Pharma: What It Is, Why It Matters, the Risks, and the Solution

Pharmaceutical manufacturing is a complex process where precision and compliance are crucial. Given the sensitive nature of the products, manufacturers must comply with strict regulatory guidelines while maintaining exceptional quality. And being the first step in the production workflow, weighing and dispensing should be executed accurately, as it sets the tone for all those steps that follow.

Even minor errors in weighing and dispensing can impact the final product. Additionally, inaccuracy can lead to regulatory risks, material loss, rework, and other negative impacts.

An integrated weighing and dispensing ERP solution standardizes the workflow, ensures accuracy, and supports compliance efforts of the company. Let’s dive deep into weighing and dispensing processes in the pharmaceutical manufacturing industry.

If you are looking to overcome the shortcomings of the weighing and dispensing process in your organization, our guide can help you.

Download 'A Comprehensive Guide to Solving Weighing and Dispensing Risks' Guide

What is Weighing and Dispensing and Why Does it Matter?

Weighing and dispensing is a process of extracting active pharmaceutical ingredients (APIs), excipients, reagents, intermediates, coating materials, and solvents in powder, solid, or liquid form from storage or containers, weighing the exact amount as per the prescribed formula, and transferring them to the production stage.

Weighing and dispensing are foundational to pharmaceutical manufacturing, and getting it right is crucial to ensure quality, consistency, and compliance with regulatory requirements.

1. 1. Product Consistency and Quality: Pharmaceutical product effectiveness is highly dependent on the accurate proportions of each component in its formulation. Since these formulations are often intricate and sensitive, even minor weighing errors, inconsistencies, or incorrect dispensing methods can significantly compromise product potency, efficacy, and safety, ultimately putting patient health at risk.
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   2.    Regulatory Requirements: Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP), FDA regulations, and other international guidelines which are designed to ensure the safety, efficacy, and quality of medicinal products. Deviations from these standards can lead to compliance penalties, costly batch recalls, and long-term damage to customer trust and brand reputation.
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   3.    Cost Efficiency: The raw materials utilized in drug production are often sensitive, expensive, and vulnerable to environmental exposure. Inaccurate weighing and dispensing processes result in material wastage, contamination, or degradation, resulting in substantial financial losses. Streamlined and precise weighing and dispensing operations minimize material waste, reduce production downtime, and improve overall operational efficiency, which helps lower production costs and maximize profitability.

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2. 4.    Traceability: Pharma manufacturers must maintain end-to-end traceability to comply with regulations and be audit-ready. A streamlined and automated weighing and dispensing solution facilitates recording, labeling, and documenting, which helps track batches effectively in case of discrepancies or recalls.
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   5.    Operational Efficiency and Productivity: An efficient weighing and dispensing solution accelerates the manufacturing process, optimizes production schedules, and reduces the potential for human error, increasing overall throughput. Automated and integrated systems reduce manual interventions, enhance accuracy, and enable production teams to focus on other critical tasks.

Key Challenges of Weighing and Dispensing

Though a seemingly simple process, weighing and dispensing is complex and faces challenges that risk its accuracy. These challenges range from manual errors to a lack of standardized processes, from inadequate accuracy to traceability gaps. Recognizing these challenges can help pharmaceutical manufacturers address them effectively.

1. 1.    Manual Errors: Maintaining accuracy consistently is a non-negotiable requirement in this industry. However, the industry still relies heavily on manual operations that are prone to errors, such as: 
2. a.    Miscalculation, misreading, counting errors, improper labeling can compromise entire batches 
   b.    Contamination due to improper handling or lack of proper containment zones risks product safety and compliance
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   2.    Lack of Standardized Processes: Manual or inconsistent workflows introduce variations in material weighing and dispensing across every batch. Such variations result in products that fail to meet the required specifications. This unpredictable quality leads to costly batch rejections.
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   3.    Documentation Burden: Being a regulated industry, pharmaceutical manufacturing must maintain meticulous documentation, accurate record-keeping, and end-to-end traceability. When the documentation is manual, it consumes significant skilled labor hours, increasing the likelihood of errors, unnecessary rework, and production delays.
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   4.    Equipment Deterioration: Accurate weighing relies heavily on properly maintained and calibrated equipment. When weighing apparatuses experience wear and tear without timely maintenance and calibration, they introduce inaccuracies. 
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   5.    Inadequate Inventory Management: Manual dispensing can result in the unnecessary consumption of excess materials, leading to waste and disrupted inventory levels. Poor inventory management triggers urgent procurement, inventory shortages, and production delays, negatively affecting operational efficiency.
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   6.    Traceability and Compliance Gaps: End-to-end traceability of every ingredient is essential for compliance. When weighing and dispensing processes are disconnected from manufacturing systems, isolated data silos emerge, breaking ingredient traceability and creating significant compliance and audit risks.

These challenges can be detrimental to manufacturing operations and can effectively bring down productivity. To understand more about the risks of manual and disconnected weighing and dispensing process and their solution, download our:

Comprehensive Guide to Solving Weighing and Dispensing Risks

Regulatory Expectations for Weighing and Dispensing Process

Pharmaceutical manufacturers must adhere to multiple global regulations for weighing and dispensing. It is important to comply with these regulations to ensure consistent product quality and avoid penalties. Here are the regulations they need to adhere to:

1. 1.    Good Manufacturing Practices (GMP), FDA and EMA: 
   Good Manufacturing Practice (GMP) comprises critical guidelines ensuring the safe and effective manufacturing of pharmaceutical products. GMP outlines general principles, such as process validation, recordkeeping, operator training, and contamination prevention that manufacturers must interpret and implement into their quality systems.
   The two main bodies that influence the development of GMP guidelines are FDA and EMA. The FDA (Food and Drug Administration) establishes pharmaceutical procedures and legislation, notably through 21 CFR Parts 210 and 211 (cGMP) and European Medicines Agency (EMA) provides guidelines through EudraLex Volume 4, harmonizing practices across European Union member states.
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   2.    ICH
   Pharmaceutical globalization is driving the regulatory authorities to harmonize regulations and facilitate faster drug development and production. Hence, initiatives like ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) have developed guidelines for API (Active Pharmaceutical Ingredients) manufacturing and testing that have been adopted by member countries like USA, Europe, Japan, and more. 
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   3.    Pharmacopoeia: 
   Pharmacopoeia is an important guideline for the pharmaceutical industry, outlining standards for testing drug substances, dosage forms, and analytical methods to ensure their identity, strength, purity, quality, and consistency. 
   Originally published by the United States Pharmacopeial Convention (USP), the U.S. Pharmacopoeia (USP-NF) is now widely considered the global standard and influences other national and international Pharmacopoeias. In many countries, including the United States, national Pharmacopoeias carry legal authority and are mandatory guidelines for pharmaceutical products.
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   4.    International Organization for Standardization (ISO): 
   A key ISO standard relevant to pharmaceutical weighing quality is ISO 9001:2008, that establishes criteria for effective quality management systems. Although not legally binding, ISO 9001 certification, issued by third-party certification bodies, is widely adopted, with over a million organizations across 170 countries certified, driven largely by purchaser requirements for supplier compliance.

Risks of GMP Non-Compliance

Non-compliance with GMP regulations carries severe consequences for pharma manufacturers. In case of non-compliance, FDA enforces compliance through a structured process as follows:

1. 1.    In the first stage, post inspections, the authorities’ document concerns in a Form FDA 483 following inspections. 
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   2.    Companies are required to respond within 15 days.
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   3.    In case the response is unsatisfactory, the FDA issues a formal warning letter detailing significant GMP violations
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   4.    The companies must submit corrections within three weeks. 
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   5.    In case of failing to adequately resolve these issues, FDA can impose penalties, batch recalls, or operational shutdowns. 

How Does an Integrated Weighing and Dispensing Solution Help?

An integrated weighing and dispensing solution digitally integrates weighing equipment, dispensing stations, and Enterprise Resource Planning (ERP) systems. This integrated system standardizes and automates the weighing and dispensing workflows to improve accuracy, traceability, and compliance assistance.

The integrated ERP solution for weighing and dispensing solves the major challenges associated with manual processes and disconnected systems such as data siloes, traceability gaps, inefficient workflows, and human errors.

Let’s look at a use case that demonstrates the effectiveness of an integrated weighing and dispensing ERP solution.

Suppose a global pharmaceutical manufacturing company is producing a new batch of drug that includes multiple APIs and excipients. These components must be weighed precisely as per the formulations while following the regulatory guidelines and traced throughout the process.

An integrated weighing and dispensing solution connected directly with the ERP enables:

1. 1.    Material Selection: The system automatically suggests the correct materials. It also has a validation stage to prevent incorrect material, incorrect quantity, or expired ingredients being used in production. 
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   2.    Equipment Availability: Before the weighing operation begins, the system identifies availability and capacity of scales after evaluating results of calibration tests, the competence, and precision of the scale.
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   3.    Traceability: Every dispensing batch is tracked from start to finish. Movements are logged in real time enabling full traceability for audits or investigations.
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   4.    Inventory Updates: As materials are weighed and dispensed, the system updates inventory records directly in the ERP. This ensures real-time accuracy across the production and supply chain.
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   5.    Error Reduction: On-screen instructions and built-in checks reduce the chance of manual errors. Operators are guided through each step, to improve consistency.
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   6.    Labeling: To facilitate compliance, labels that include all relevant batch, material, and expiry information are generated instantly. 
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   7.    Compliance: E-signatures for material approval and dispensing are captured to support FDA 21 CFR Part 11 and internal quality protocols.

Key features of an integrated weighing and dispensing solution include:

1. 1.    Real-time data 
   2.    Automatic inventory updates
   3.    End-to-end traceability
   4.    Automated documentation 
   5.    Equipment maintenance

Benefits of an Integrated Weighing and Dispensing ERP Solution

An integrated ERP solution for weighing and dispensing can be a game changer in a pharma manufacturing organization. Let’s look at a few benefits of an integrated ERP solution:

1. 1.    Automatic Material Identification: The solution identifies and verifies whether the material being weighed and dispensed is correct for production. It also prevents the use of expired raw material. The integrated solution automatically transfers weighed material data into the ERP. 
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   2.    Instant Inventory Reconciliation: An integrated solution eliminates data siloes between production, weighing and dispensing stations and can, hence, automatically update and reconcile inventory levels, minimizing the risk of stockouts.
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   3.    Standardized Workflows and Maintenance: An integrated ERP solution standardizes the workflows and guides the personnel to ensure quality and consistency. It also streamlines maintenance and calibration schedules to minimize equipment wear and tear and optimize production downtime.  
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   4.    Streamlined Documentation and Labeling: An integrated ERP solution automates documentation and supports compliance through e-signature approvals. It also reduces errors by directly creating accurate labels from the ERP system.
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   5.    Enhanced Traceability: Maintains detailed records of raw materials, ensuring full traceability throughout the production process.

Conclusion

The Weighing and Dispensing process is a crucial part of pharmaceutical manufacturing and plays an important role in ensuring quality, consistency, and compliance. However, manual processes and disconnected weighing and dispensing solutions are the root causes of multiple challenges that ultimately risk product quality.

It is important to tackle the challenges with a robust solution that can streamline the process, automate repetitive tasks, and support compliance efforts. An integrated weighing and dispensing ERP solution can overcome these challenges and improve operational efficiency, reducing wastage and minimizing business disruption.