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The responsibilities of contract manufacturing organizations (CMO) go beyond simply producing quality products for their clients. They must also be open to collaborating with them while providing clear lines of communication and transparency during the entire manufacturing process. 

Unfortunately, accomplishing these goals is difficult when using a paper-based system or relying on multiple software systems that are incompatible. 

To provide contract manufacturing facilities and their customers with the resources they need, our team has updated InstantGMP™ PRO, our all-in-one manufacturing and quality system, with new features that improve processes, communications and oversight.  

Below, we’ll discuss the roles and responsibilities that contract manufacturers have to their pharma, dietary supplement and biotech clients and how our newly upgraded software can benefit both parties in ways they have never previously experienced.  

The Role of CMOs for Pharma & Dietary Supplements 

When a pharma or dietary supplement company does not have their own manufacturing capabilities, they engage with a contract manufacturing organization (CMO) to make their new product for them. 

A CMO can provide manufacturing solutions to pharma or dietary supplement companies in three distinct ways:

  • The CMO formulates the product by determining the exact materials and necessary process steps. 
  • The pharmaceutical or dietary supplement company provides the CMO with a set of processes which they follow to create the product. 
  • The pharmaceutical or dietary supplement company selects a predetermined recipe from the CMO of a product that it currently manufactures. This option (known as “White Labeling”) allows a pharmaceutical or dietary supplement company to apply their label to an existing product created by a CMO and sell it under their own brand. 

While all these options seem straightforward, CMOs and their clients often encounter problems during the manufacturing process. Most of these issues involve the limitations of paper-based or outdated software systems with regards to creating Master Production Records (MPR) and Batch Production Records (BPR)

Issues Encountered During Contract Manufacturing for Pharma & Dietary Supplements

Although a CMO client may not have a manufacturing facility, they often want strong oversight of the formula design, manufacturing instructions creation, and materials selection. In essence, they want to supervise the creation of the MPR to ensure that it meets their exact needs and specifications. 

To provide this oversight, a CMO drafts an MPR on a paper document or electronic file (ex. Excel spreadsheet) and shares it with the client. After receiving and reviewing the document or electronic file, the client will make their revisions and send it back to the CMO. This process continues until a final document is approved. 

Unfortunately, this traditional process creates multiple problems for all parties involved. Since multiple revisions of a paper document or electronic file exist, there is a strong possibility that the information in the “final draft” is not 100% accurate. 

This could be due to a variety of reasons, including 

  • The inclusion of outdated information that was not properly deleted from a previous draft 
  • The omission of a key member of the company during the review process 
  • Critical information or instructions missing from the final draft
  • Lack of access to the document or file
  • The inability to include an electronic signature for review/approval purposes 

To solve these issues for CMOs and their clients, InstantGMP™ updated our software with new features. 

Interactive Customer Experience for CMOs 

To help avoid the above mentioned issues, InstantGMP™ has created an innovative Interactive Customer Experience feature that simplifies the MPR process, improves CMO/client communications, and provides greater oversight during the entire manufacturing process. 

Our InstantGMP™ PRO software now includes an external user feature for pharmaceutical/dietary supplement/biotech manufacturers that allows their customers to access MPRs and BPRs online. 

Not only does this external user feature let customers conveniently and confidentially access MPRs and BPRs from anywhere, it also allows them to 

  • Review MPRs and BPRs during the design phases 
  • Check the status of a BPR 
  • See real-time results when a batch is in production 
  • Receive notifications/emails when a deviation occurs during production 
  • Respond to alerts in Requests For Actions 
  • Leave comments which become permanent parts of the respective record 
  • Approve MPRs and BPRs with an electronic signature 

With this unique feature, CMOs can benefit from an unprecedented amount of engagement with their customers during the design phase (when they are creating an MPR) and the production phase (when they are running a batch). 

Separate from the new Interactive Customer Experience feature, InstantGMP™ PRO also provides the ability for our Electronic Batch Records (EBR) to provide costing. 

Simplified and Accurate Costing For CMOs 

One of the other challenges that CMOs face when using a paper-based system is keeping track of material/labor costs to determine estimated costs, total costs and final pricing. There are too many opportunities for inaccurate information to be included and accurate information to be excluded in a paper-based system. When those scenarios occur, it can significantly impact a CMOs profitability. 

With InstantGMP™ PRO’s new feature, CMOs can track material and labor costs directly in the Batch Record. As materials are added to a batch, the cost of each material is totaled. Similarly, when operators and supervisors enter their hours, the feature automatically calculates the labor rates. 

CMOs can use this information to determine estimated costs before production and compare it to the actual cost when the production is completed. After reviewing the total cost, CMOs can add markups and calculate the batch price (the cost to their customer). Once the batch price is confirmed, the costing feature calculates the price per unit and attaches that information to the inventory system for future use. 

Conclusion:

Since the introduction of our InstantGMP™ PRO, our team’s goal was to continue to update and refine this software to offer unparalleled solutions for GMP facilities. 

By adding the new external user feature to our all-in-one manufacturing and quality system, CMO customers can enjoy an unprecedented amount of oversight and participation in the design and production processes. 

Plus, CMOs can rely on the costing feature to more easily and accurately track and calculate their material prices and labor rates to reflect their overall costs and determine final batch pricing. 

To see a demonstration of InstantGMP™ PRO’s new Interactive Customer Experience and Costing features for CMOs, please, contact our team today!  

 

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