ISO 15378

PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS

Introduction:

ISO 15378 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

ISO 15378 requirements include compliance to ISO 9001 and Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system. Where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.

Good Manufacturing Practice (GMP) is a term that is renowned worldwide for the control and management of manufacturing, testing and final quality control of food / beverage and pharmaceutical goods and their primary packaging. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency, and quality of pharmaceutical products, cosmetic products and edible products and their primary packaging.

The quality approach of GMP guarantees to enable organizations to limit or eliminate instances of contamination, mistakes and errors. This thus shields the customer from purchasing an item, which isn’t effective or even dangerous. It is accepted that GMP is one of the best business tools, which will refine both the compliance and performance of the organization.

Who can apply for ISO 15378 certification?

The certification is availed primarily by companies that are into the design, manufacture, and supply of primary packaging materials for medicinal products. This standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001 system is needed.

ISO 15378 Implementation Points

Integration of customer requirements specific to primary packaging materials for medicinal products.
Streamlining and Standardizing the manufacturing processes and other business processes
Manufacturing Process Control and Monitoring
Risk management and Contingency planning
Formulating Quality Policy and Objectives
Setting up a system for documentation and records.
Management information system
Business Performance and Sustainability

Benefits of ISO 15378 to Primary Packaging Material Manufacturer after Implementation

Entry passport for supply to the customers from pharmaceutical field.
Recognition of the certificate and the system by other industry sectors
Cost-effectiveness at various stages of the operations of the organizations
Improved product safety and warranty management
Manufacturing process controls enhance Quality and Productivity
Business process streamlining and efficiency improvement
Responsibility and Accountability across the organization
Better business performance and Enhanced sustainability

Who can apply for ISO 15378 certification?

ISO 15378 Implementation Points

Integration of customer requirements specific to primary packaging materials for medicinal products.
Streamlining and Standardizing the manufacturing processes and other business processes
Manufacturing Process Control and Monitoring
Risk management and Contingency planning
Formulating Quality Policy and Objectives
Setting up a system for documentation and records.
Management information system
Business Performance and Sustainability

Benefits of ISO 15378 to Primary Packaging Material Manufacturer after Implementation

Entry passport for supply to the customers from pharmaceutical field.
Recognition of the certificate and the system by other industry sectors
Cost-effectiveness at various stages of the operations of the organizations
Improved product safety and warranty management
Manufacturing process controls enhance Quality and Productivity
Business process streamlining and efficiency improvement
Responsibility and Accountability across the organization
Better business performance and Enhanced sustainability

How Neozenith helps in the Implementation of ISO 15378

ISO 15378 being a specific standard for primary packaging materials for medicinal products, the required controls and monitoring of the quality management system and actual on-floor practices are very specific and stringent. In such a scenario, the practical, easy, and effective implementation of the system is very essential. Neozenith team with expertise of more than 6 years has supported many clients implement GMP and get ISO 15378 certification.

The ISO 15378 implementation process is described below:

Gap analysis, review of the existing Quality Management System. This review is carried out through discussions and verifications of records during visits to the client organization. The pharma customer-specific requirements are taken into consideration to make this activity effective.
GMP-based system designing and documentation (Records and Procedures). 100% documentation support is offered by Neozenith. This includes shop floor controls as well as control of documentation and records.
Training on GMP and QMS-related requirements
Routine assistance and system verification to ensure compliance with the requirements.
Internal audit and Management review
Certification audit – Stage 1 and Stage 2
Submission of the action plan on audit observations
Review of reports by the certification authority and awarding the certificate to the organization.

ISO 13485

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS

Introduction:

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Putting the regulatory considerations aside, implementing an ISO management system standard into your business represents good management practice, or in the case of medical devices “Good Manufacturing Practice (GMP)”. By implementing ISO 13485, an organization becomes a better bet for their suppliers. Not only they have implemented important controls directly related to medical device manufacturing, but also, they have provided efficiencies and effective management through:

A documented approach to management
Policies, objectives, and planning
Control of documents
Control of records
Reviews
Internal audits
Product non-conformances and continual improvement

What is the role of the customers in all of this? Of course, the customer is also king, and all the regulations in the world make no difference to your business if you can’t attract and satisfy your customers enough. Many companies can design product and promote, but it is the consistent quality and attention to customer satisfaction that brings long-term success in the market. Customer satisfaction, of course, is a prime goal of the ISO 13485 standard; no wonder it’s appealing to customers. Proving yourself as a good and consistent supplier to your customer can be improved by certification to an ISO management system standard. As the importance of compliance and satisfaction grows, you will be able to draw the attention of a number of customers who will not work with non-ISO certified organizations. Many organizations are finding that no matter how good their product is, customers need more reassurance, they want their suppliers to be certified. Moreover, many organizations are finding that losing even one contract can well pay for the cost of implementing good management practice and getting certified. If your management system was well documented and implemented, you just might even enjoy life a little more with the knowledge that your business is in safe hands and operated, as it should.

For medical device manufacturers or suppliers who are looking for opportunities to grab new markets, conformity with regulatory requirements is a mandate. If you are one of those entrepreneurs who want to avail the competitive advantages in the medical device manufacturing industry, ISO 13485 certification is an ideal choice for you!

Benefits of implementing ISO 13485 Certification to your Customers:

Quality ensured medical devices
Improved Customer Satisfaction
Improve your process
Create a culture of continual improvement
Ability to Contract with Larger Companies

Increased profit margins
Improved product safety
Cost Savings
More Effective Risk Management
Increased likelihood of meeting Customer Requirements
More Effective Risk Management
Increased profit margins
Increased access to worldwide markets

What kind of Organizations can go for ISO 13485 Certification?

Any Organization who is into one or more life cycle stages of Medical Devices can get certified to the ISO 13485 Standard. Organizations involved in the concept design, development, production, storage, sales/distribution, installation, servicing, final decommissioning, and disposal stages of medical devices can get certified to the ISO 13485 Standard. Moreover, Organizations can get certified to the ISO 13485 Standard irrespective of their size (number of personnel) and the type of Organization. Our ISO 13485 Consultants will help you with the process steps to get certified.

How can Neozenith help?

Gap analysis for each and every activity of the organization and preparation of the detailed report.
Preparation of applicable documents required by ISO 13485, based on the detailed study of all activities of the organizations, such as:
ISO 13485 Quality Manual.
ISO 13485 Quality Procedures (mandatory procedures required by the standard).
Identification of applicable regulatory requirements and ensuring compliance with the regulatory requirements and as per customer requirements.
Standard Operating Procedures (SOPs) to control identified activities having risk potential to the human during the use of such medical devices;
Formats to establish the objective evidence of implementation and to ensure control over all the activities;
Training on ISO 13485 standards to all employees within the organization,
Virtual and on-site support in effective implementation of the ISO 13485 system by periodic visits till ISO 13485:2016 certification.
Conduct an internal audit to check readiness for the certification.
Certification audit – Stage 1 and Stage 2
Submission of the action plan on audit observations
Review of reports by the certification authority and awarding the certificate to the organization.

ISO 9001

QUALITY MANAGEMENT SYSTEM

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. Successful businesses understand the value of an effective Quality Management System that ensures the organization is focused on meeting customer requirements and they are satisfied with the products and services that they receive. ISO 9001 is the world’s most recognized management system standard and is used by over a million organizations across the world.

The ISO 9001 standard promotes the adoption of a process approach emphasizing value addition, effective & efficient process performance, and continual improvement through objective measurements & monitoring.

To be certified, you need to implement an effective quality management system complying with the requirements of the standard.

Benefits for your Organization:

Our ISO expertise will provide your team with coaching and technical services in order to ensure your transition project is moving forward in timely and efficient manner.

Our support service for the transition to ISO 9001includes the following:

Step – I Preparation & Training

Conducting gap assessment including risk & opportunities for improvement
Identifying the need for additional documentation
Preparing an action plan that includes tasks, assignments and schedules
Training to employees on the ISO 9001standard
Evaluating key performance indicators to update or modify current quality objectives.

Step – II Implementation Support

Measuring & Monitoring objectives to ensure targets are achieved.
Preparing & Validating documented information
Providing appropriate training to internal auditors
Assisting the ISO team in monitoring the implementation
Assisting the audit team in the internal quality audit process.

ISO 22000

FOOD SAFETY MANAGEMENT SYSTEM

ISO 22000 is a preventative and HACCP-based system that is adaptable to any size business participating in the food chain supply. It is applicable to feed producers, food manufacturers, transport and storage operators and subcontractors to retail and food service outlets. The ISO 22000 standard is focused on the development, implementation and improvement of a Food Safety Management System. Those who are involved in food processing, manufacturing, and distribution should adopt and implement ISO 22000. By successfully implementing the Food Safety Management System, your organization gets the advantage of certification against ISO 22000 certification. Getting ISO 22000 certification also satisfied your customer in terms of safe food, better quality and reliability in food industries.

Why ISO 22000;

Working environment improves with ISO 22000.
Compliance with the legal requirements of the ISO 22000 organization is ensured.
With ISO 22000, it is ensured that the customer portfolio that seeks care and importance in the food industry is reached.
Correct planning with ISO 22000 enables good work to be done in both production and service.
With ISO 22000, inspection periods pass easily.
Conscious personnel and resource savings are achieved with ISO 22000.
Systematic management and control of prerequisite programs with ISO 22000.
With ISO 22000, you gain prestige and reliability.

What are the various steps involved in establishing ISO 22000 Management System?

Analyse the gaps
Identify food safety hazards, risks involved and legal requirements
Define roles and responsibilities of all towards FSMS
Develop food safety policy, procedures, documentation, objectives & targets
Assist to conduct Internal Audit and Management Review

The food industry continues to see numerous changes in terms of food safety. This has included new regulatory laws, increased demand for higher standards from retailers and customers, urgency in developing new processes to meet food safety standards, increased demand for training and a renewed commitment to the development of a food safety culture. Managing these changes is no easy task, and organizations must be prepared.

Today’s consumers need assurance that the food they eat is free of any potential health hazards. There are many best practices the food industry can follow in terms of preventing health hazards when preparing and storing food but this is only the first step. Adopting a food safety certification program is critical in showing commitment to ensuring a safe food supply chain.

Neozenith is ready to be your partner on this food safety journey. Our food safety teams are not only focused on evaluating your business processes against food safety standards, but we also understand how compliance – together with best practices and your brand standards – can help reduce risk, as well as improve the efficiency, economy, quality, and profitability of operations.

ISO 14001

ENVIRONMENTAL MANAGEMENT SYSTEM

The ISO 14001 Standard is a standard prepared to minimize the damage caused by organizations to the environment and to create a more liveable environment in the future. ISO 14001 lays out the needs for an Environmental Management System (EMS). It is for all types of businesses. A good system helps you reduce your impact on the environment. Implementing a good EMS demonstrates your commitment to the environment. Some companies require their vendors to have an EMS in place, so it can also help you grow your business. The purpose of ISO 14001is to help organizations design, implement, and maintain effective Environmental Management Systems which can be audited and certified.

An EMS lays out the broad framework of an organization’s impact on the environment and sets goals to monitor and control its impact on the environment. It also ensures compliance with your applicable regulatory requirements.

Why ISO 14001;

Thanks to ISO 14001, you can minimize the amount of waste
With ISO 14001, you can reduce your organization’s energy consumption
With ISO 14001, it becomes easier to obtain permits and authorization documents.
Compliance with national and international legal requirements with ISO 14001
Thanks to ISO 14001, with the correct use of natural resources, costs are reduced and productivity increases.
With ISO 14001, potential dangers are analyzed, so that accidents and losses are reduced.
With ISO 14001, customer trust and loyalty increase by guaranteeing that the activities are carried out under environmental obligations.

What you earn with ISO 14001;

You will have obtained a green passport in accessing reputation and recognition, products and services in national and international platforms.

ISO 45001

OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM

ISO 45001 occupational health and safety is a management system created to create and manage a healthy and safe working environment by eliminating or minimizing the risks in the organization in the light of the relevant legal regulations. Every year, health and safety risks cost businesses a lot of money. Implementing a robust and effective management system like ISO 45001 can help a business reduce the risk of costly incidents, improve safety performance, establish a responsible image in the marketplace and meet regulatory and statutory requirements.

Why Organization need ISO 45001:

With ISO 45001, you minimize the rate of occupational accidents and occupational diseases and prevent loss of workforce.
With ISO 45001, you ensure staff satisfaction by obtaining a good working environment within the organization.
With ISO 45001, you prove the organization’s sensitivity to occupational safety in front of legal parties.
With ISO 45001, you gain competitive advantage by increasing the organization’s reputation.
With ISO 45001, you prevent the stopping and slowing of production due to accidents and diseases, and you will reduce the compensation expenses, penalties and compensations, and you will have the opportunity to reduce operating costs.
With ISO 45001, you get a potential reduction in downtime and the costs associated with it. happens.
With ISO 45001, you ensure the systematic spread of occupational health and safety activities within the organization.
With ISO 45001, occupational health and safety helps you become an organization that complies with relevant national and international conditions and laws.

Earns with ISO 45001;

With ISO 45001, your institution’s reputation increases and you gain a reliable company image both in the industry and in the public eye. Safe environment safe activity equals ISO 45001.