Compliance and Quality
- The overview
- Product lifestyle management
- Audits and inspections
- Qualified person and responsible
- Responsible person services for wholesaling of medicinal products and active pharmaceutical ingredients under gdp
- Life cycle management
- Quality validation activities
- Quality training
- Audit and inspection
The Overview
The Compliance and Quality Department is responsible for offering services that include the QP led auditing, batch release services, the establishment of quality management services, vendor qualification, and supply chain compliance activities.
Qualified and Responsible Person Services
Our services include both Qualified and Responsible Person, who will meet your needs for offering products across the product lifestyle.
Product Lifestyle Management
Our QPs are responsible for offering support through their lifecycle for a product. They do so by evaluation which is then followed by leading the management of the third-party vendors, internal quality practices, and the overall validation of activities.
Our services also include the following:
- Vendor auditing and evaluation
- Supply chain compliance
- Quality training
- Quality validation activities
- MAA compliance
Audits and Inspections
The team of professional QPs and QAs are renowned for their auditing. We are known for offering global coverage for compliance surveillance. This is done to ensure that the manufacturing sites meet the demands laid down by the EU regulations for the entry of a product.
Our list of services also includes:
- Inspection preparedness.
- Audits and inspections led by QP.
- Computer system audits
- Quality systems auditing and review
- General cGMP compliance audits
- MAA compliance audits
Qualified Person and Responsible
Our qualified team has detailed knowledge about the full range of dosage forms and process.
These include:
- Tablets
- Liquids, creams and both sterile and non-sterile ointments
- Capsules comprising of both hard and soft shell
- From packaging supplies auditing to labelling, covering leaflets, attending to cartons, foils & films - we do it all. Our experts will handle the primary containers to GMP and PS9000:2016
- Sterilisation by filtration, irradiation and ethylene oxide
- Excipient supplier auditing to IPEC-PQG guidelines
- API supplier auditing for both the small and large molecule in respect of the EU GMP Part II/ ICH Q7
- Auditing of contract analytical laboratory to ISO 17025:2017 and GMP.
- Mapping the supply chain to take care of the potential risks and complying with the Directives of Falsified Medicines 2011/62/EU
- Storage and distribution warehouse auditing to GDP
RESPONSIBLE PERSON SERVICES FOR WHOLESALING OF MEDICINAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS UNDER GDP
Our professionals also work as contractors based on the needs of your or the third-party Wholesale Dealers Authorization. This includes medicines for both human and veterinary, all of which falls under the European Guidelines 2013/C 343/01 human medicines. The 2015/C95/01 API for medicinal products required for human use.
Quality Defects and Product Recalls.
We will not only investigation the complaints your product is facing but also investigate the root cause behind the problem. Our qualified professionals will ensure that the problem is taken care of and under no circumstances occurs again. If you ever face the challenge of a product recall, then we will offer the necessary guidance required for you to interact with the respective National Regulatory Agencies.
Life Cycle Management
Product Life Cycle Management and Vendor Qualification
Sunshine Consultancy will conduct thorough and in-depth research as well as audit to ensure that the vendor has the power to maintain full compliance with the current GxPs and satisfy every additional specific issue that has been specified in your Market Authorization.
Our services also include evaluation, selection, auditing, and monitoring of the GxPs for the following:
- API suppliers [EU GMP Part II] *
- Excipient suppliers
- Sterilisers
- Packaging material suppliers [PS9000:2015]
- Contract Analytical Laboratories
- Supply Chains
- Centres for storage and distribution
- Contract Manufacturing Organisations
Our professionals have the experience required to interrupt the quality system in compliance with the lifecycle and assist the Quality Departments to conduct an audit and coordinate it with the operational activities in the following areas:
- API QP Declarations*
- The development of programmes for vendor audit.
- Quality Risk Management
- Complaints and Product Recall
- Quality and Technical Agreements
- Site Master Files
- Quality Management Systems
- Change Management
- Marketing authorisation compliance audits.
The European Regulatory Authorities have finally accepted the use of the third-party audits. With the use of our authentic consultancy services, we can now ensure that you have complied to all the obligations mentioned in Article 46(f) of the Directive 2001/83/EC. We also offer personalised reports based on all the information required by the QP of your company. It will help to facilitate the Declaration of GMP Compliance for all your API suppliers. We will get the API QP Declaration for you.
Quality Validation Activities
We will offer you the guidance required in respect of facility commissioning, qualification, and validation activities. The complicated and highly confusing validation requirements can be taken care of by our experts on your behalf. We will ensure that the companies are proceeding forward with their activities and meeting the standards set by the current regulations.
We also offer our expert services for the following
- Process Validation
- Cleaning Validation
- Equipment validation.
- Computer systems and software validation
Compliance with the falsified medicines directive.
We can make the process of understanding the complexities of your supply chain easy for you. This will eliminate all the risks that your product was facing. Everything will be done according to the Falsified Medicines Directive 2011/62/EU.
Our services also include the following:
- We will select, evaluate and define transportation routes and contingency plans.
- Selection, evaluation, auditing and validation of transportation companies.
- Selection, evaluation, verification and validation of storage and distribution centres.
- We will not only develop but also improve your Quality & Technical Agreements with your suppliers and third parties; defining respective GxP responsibilities; and supporting effective vendor management as required by EU GMP Chapter 7 Outsourced Activities.
- Evaluation of API and Finished Dosage Form transportation from manufacturer to end users.
- Marketing authorisation compliance audits.
Quality Training
We will offer training to your Quality Department following the needs of the organisation. Our team is renowned for building programmes that will ensure continuous improvement of your organisation. It will also help to build the superior quality your company needs.
Audit and Inspection
Regulatory Inspection Preparation
Before the Regulatory Agency conducts, it's inspection we can undertake the task of conducting a pre-approval inspection and gap analysis for you.
The auditors who work for Sunshine Consultancy have the required experience needed. They are also familiar with 60 regulatory inspections that are followed by different agencies like the HPRA in Ireland, MHRA in UK, SUKL in Czech Republic, FDA in the USA, EMA, Korean FDA, Turkish MOH, MCC South Africa, Anvisa Brazil, and in countries like India, Bangladesh, Argentina, England, Ireland, and Czech Republic.
Our services include:
- Every area related to the GxP will be inspected thoroughly before conducting the pre-approval regulatory inspections.
- Every area associated with the GxP will undergo mock regulatory inspections.
- We will offer you the necessary guidance regarding the corrective actions that should be implemented and validated before the actual regulatory inspection. This gives companies the opportunity to take care of issues prior to them being cited as regulatory non-compliances by the inspector.
- Providing proper training on how to conduct a successful regulatory inspection through mock inspection interviews. We also offer a list of ‘Do’s and Don’ts’ that should be followed at the time of Regulatory investigation.
- We will prepare you for unannounced inspections that are becoming very frequent these days.
- With the use of practice standards, we will review your level of compliance. This will include the renewal or retention of the necessary licences, such as MIA, WDA, MA, GMP and GDP.
Computer System Audits.
The team of expert professionals working for us will assist you regarding how to use computer systems to meet the requirements set by cGMP. We will make sure your vendors comply with the needs of the GMP validated system.
General CGMP Compliance Audits
We offer both one time and annual basis cGMP Compliance Audits. We also offer impartial and flaw audits and highlight the areas that need improvement.
Quality Systems Review
You can only adhere to the cGMP if you are following a strong and a well-defined Quality System. However, it can be quite tricky given the legislation are changing now and then. We will ensure that you are equipped with a system that meets current requirements and is prepared for the upcoming ones.