Pharma Co-packaging Regulations

Contract packaging is a common trend in Pharmaceutical industry where part or whole of manufacturing operations are carried out by third party organization. This organization contain and maintain its own equipment, resources, and personnel without depending on the pharma manufacturer. However, third party is responsible for following all the quality and regulatory principles.

Outsourcing of packaging operations to third party organization, requires a great responsibility on the pharma manufacturer that intends to give contract to third party. It is responsible for the quality safety, reliability and integrity of the product being outsourced in line with the latest and approved regulatory requirements.

Co-packaging operation

Contract packaging operations is outsourcing only packaging operations to the third party, rather than entire manufacturing operations. The third party maintains their packaging equipment, systems and personnel, and use to provide packaging to pharma manufacturers. 

The contractor cannot market or manufacture its own product, nor can it start its own manufacturing operations. 

When a pharma manufacturer opts for co-packaging, it is responsible for regulatory compliance. It is also responsible for ensuring regulatory compliance by the contract third party. 

here can be many reasons of using contract packaging, some of them are mentioned below

• The pharma manufacturer has not enough resources to maintain its packaging facilities

• The requirement of pharma product is large, and cannot be processed by the existing resources.

• There is any problem or fault, that pharma manufacturer cannot use its packaging resources for the current batch

Co-packaging regulations

Like every pharma manufacturing, contract packaging is also governed by regulatory requirements of a particular market and country. All the regulations for pharma manufacturer are applied to the third party contractor. Additionally, some regulations are also added for correct production process and product.

Let’s discuss some regulatory requirements for contract packaging in line with three most competitive markets i.e China , United States and Europe. For the China, the regulatory body is NMPA, for the Unites States, the regulatory body is FDA and for the Europe, the regulatory body is EMA.

National medical products administration – NMPA

National medical products administration regulatory body that controls the manufacturing and distribution of pharma products in the territory of China. The NMPA guidelines are called “Good Manufacturing Practice for Drugs”. It is divided into 14 chapters , with Chapter 11 being related to contract manufacturing. 

For contact packaging, there are no specific guidelines. Instead good manufacturing practice provide guidelines for the general contract manufacturing of pharma products, including the packaging.

United States FDA 

Food and Drug administration is a regulatory body for the United states and regulates manufacturing, production, and marketing of pharma products in the United states 

For the pharma contact packaging, there is no specific guidelines. However, FDA has created various guidance for contract manufacturing, which can also be used for contract packaging. Among these guidance documents, following are the most relevant

• ICH Q7 good manufacturing practice guidance: it includes generalized guidance for the manufacturing of pharma products. Although, contract manufacturing  including packaging is provided with separate guidelines, it is necessary for contract acceptor to follow all the good manufacturing practice guidelines

• ICH Q9 quality risk management: it includes procedures for assessing, control, and review of risks to ensure quality of pharma product, until it reaches its intended user. For contract manufacturing operations, it provides guidelines in the section II.5 “Quality risk management as part of materials management”, under the section “Assessment and evaluation of suppliers and contract manufacturers”

• ICH Q10 pharmaceutical quality system: This guidelines relates to the implementation of a quality model for pharma manufacturers called Quality Management System. for contract manufacturing, it provides guidelines in the section “Management of Outsourced Activities and Purchased Materials”

European Medicines Agency – EMA

The European medicines agency – EMA is responsible for regulations of pharma product in European countries or European Union. It ensures safe, quality and reliable production and distribution of pharma product within its jurisdiction. These guidelines and regulations also apply to non-EU manufacturer, that intends to market or distribute its product in the jurisdiction of EMA.

For co-packaging, the guidelines are mentioned in EU – Good Manufacturing Practice. In addition to regulations related to contract packaging, the contract acceptor is also responsible for following regulations mentioned in Good Manufacturing Practice for the packaging of pharma products.

Pharma Co-Packaging regulations

Let’s look at some regulations for pharma contract packaging

• There must be a written agreement between contact giver and contract acceptor. 

• Contract giver refers to the pharma manufacturer that is entitled to manufacture, market and distribute a pharma product under its brand name, legally by the regulatory authorities.

• Contract acceptor refers to the third party contractor that performs packaging of pharma product of other pharma organization. The contract acceptor has no approved product of its own.

• The agreement should be in accordance with regulatory requirements, and there should be no, in any case violation of regulatory body regulations by the contract giver and acceptor.

• The contract giver is responsible for assessing and auditing the contract acceptor’s ability to understand the product various hazards ( environment , equipment, personal and other material)

• The contract giver is responsible for supervising the analysis, and to make sure the final product is according to the requirements that’s the meets the specifications and requirements.

• The contract acceptor has adequate resources, knowledge and experience to carry out the packaging operations.

• Contract acceptor is responsible for ensuring receipt of material from contract giver in accordance with the regulations.

• The contract acceptor should prevent any activity that could cause damage the product.

• Contract giver should assess the capability and suitability of contact acceptor in terms of resources, personnel expertise and damage handling before giving contact through inspection,  audits and qualification

• Contract giver is responsible for reviewing the contact acceptor’s capabilities and performance time to time, during the period of contract. The contract giver should also devise mechanism to implement improvements, if any

• The contract giver should ensure that the contract acceptor is using appropriate and approved sources for materials. The contract acceptor should refrain from sources that are not approved. 

• In addition to these guidelines the contractor sector is responsible to follow good manufacturing practices.

• The agreement between contract giver and contract acceptor must be specified with relevant responsibilities, with clear outcomes and objectives. It should avoid vague and unclear language terminology and abbreviations that could cause any confusion to any parties, during the course of agreement.

• The contract should be written by technical and competent persons. Irrelevant persons should be avoided as they can cause damage to the contract or any party.

• The contract should indicate that relevant person should use appropriate tools, methods and systems to ensure that each batch has been manufactured and verified for compliance

• It should be mentioned in the contract who is responsible i.e. the contract giver receptor for the following

• Purchasing material relevant to packaging material, consumables and other items involve in packaging operations.

• Testing and releasing of the final product and other intermediaries, during packaging process.

• Production and quality control

• Sampling and analysis performed during different stages of packaging process and the final stage of finished product

• It should be mentioned that record distribution and possession by the contractor acceptor should be available to contract giver. The contract acceptor should not keep any record or part of it with itself.

• If there are any recalls, complaints, or defects of a specific batch or products, it must be immediately informed to the contract giver. Its relevant record must also be provided to the contact giver by the contact acceptor.

• The contract acceptor is bound to accept evaluation, audit and inspection performed by regulatory bodies at any time. It must not, by any means try to hinder any audit or inspection.

• The contract giver’s quality department is responsible for maintaining quality of packaged product. It can reject or accept the product, depending on the final product quality.

• The contract should also include systems and practices to protect data through appropriate measures.  These measures must be part of validation or qualification activities, before start of contract.

• The contract acceptor must also ensure and implement data protection at its packaging facility, and prevent any weak systems that can trigger data insecurity or theft.

• The contract giver must analyze the contract acceptor’s compliance before giving or finalizing the contract.

• The contract acceptor should be able to generate certificate of analysis, through proper systems and procedures. If there are any change in these systems or procedures, it must be immediately notified through proper mechanism. The change should be validated for its effectiveness and compliance

• The contract acceptor should calibrate relevant instrumentation and measuring devices. It can be performed by in-house calibration services or through third party service providers. Record of calibration should be maintained for review the by the relevant regulatory body.

• If there is any warning issued to the contract acceptor, the contract giver is responsible to evaluate or asses risk on its product, in line with quality risk management. Results of these assessment should be maintained for review by the regulatory body, during routine inspection. Results of risk management should be immediately implemented, and in case, it requires, the contract should be immediately and appropriately cancelled.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.