Industry Standards Regulatory

Hazard Analysis Critical Control Point (HACCP) is a management system to uphold food safety through the analysis and control of physical, microbiological, chemical and allergenic hazards across the entire process from procurement and receipt of raw material to manufacturing, distribution and consumption of finished product. This is a mandatory requirement for all European food processing entities as per Regulation EC 852/2004 on the hygiene of foodstuffs.

We can help you conduct a gap analysis, determine Prerequisite Programmes (PRPs), design and implement a HACCP Plan and a Risk Assessment and train your people understand and implement the principles of HACCP.

Good Distribution Practices (GDP) is based on Directive 92/25/EEC and EU 2013/C 68/01 guidelines on GDP of medicinal products for human use. These requirements provide worldwide-accepted practices for the proper distribution of medicinal products for human consumption.

We can help you identify the gaps of your current system to achieve compliance and/or certification, establish procedures and train your people understand and implement them hence providing confidence to your customers of a quality assured service and a secure supply chain.

The EU governs medicinal products via the EudraLex rules and regulations. Volume 4 of EudraLex specifically addresses Good Manufacturing Practice (GMP) and presents the guidelines to ensure that pharmaceutical products are consistently produced and controlled and do not pose any risk to the consumer. GMP covers all aspects of production, training and personal hygiene of staff controlled via detailed, written procedures.

We can help you identify the gaps of your current system to achieve compliance and/or certification, establish procedures and train your people understand and implement them hence providing evidence that procedures are consistently followed throughout the manufacturing process.

EU Lifts Directive 95/16/EC amended by Directive 2014/33/EU promotes a harmonised legal framework controlling design, manufacture and installation of lifts. Passenger safety ranks high on the agenda and stakeholders are bound by Lift Regulation 2002, Inspection of Lifts Regulations 2007 and Machinery Regulations 2009. Compliance promotes free trading of such lifts throughout the EU. We can assist you in ensuring compliance with this directive.

You produce waste as a consequence of your operations. Whether it is hazardous, non-hazardous or specific waste (such as waste electrical and electronic equipment), we can help you get in line with local regulations. We will assist you to establish waste streams, monitor your impact, train your people and establish legal waste collection practices as permitted by the Environment & Resources Authority (ERA).

Specific activities are controlled through the Industrial Emissions Directive (IED) and require an Integrated Pollution Prevention and Control (IPPC) permit. LN 10 of 2013 transposing the EU IED (2010/75/EU) into national law to minimise pollution from various point sources is the local legal framework to follow. We will hand hold you throughout the process until we obtain the IPPC Permit as issued by the Environment & Resources Authority (ERA).

Smaller scale activities are regulated through a set of General Binding Rules (GBRs) which apply to all enterprises within a common group. Larger scale activities (medium-to-large scale enterprises or smaller enterprises with significant environmental impacts) are regulated through an Environmental Permit issued on an individual basis by ERA.

Whatever the size or impact of your organisation, we can determine key environmental impacts, help you in creating sustainable processes and obtain an environmental permit issued by Environment & Resources Authority (ERA).

Your workplace presents a number of hazards that need to be identified and controlled. The inherent risks might cause harm to people and it is the employer’s responsibility to determine the reasonable steps needed to prevent potential harm. We can conduct such a risk assessment to ensure an encompassing evaluation of your entire workplace.

Think about ill health and accidents and liability and actions that counteract these impacts. The risk assessment will help you evaluate these. It needs to be reviewed on an on-going basis and re-considered especially if new equipment, processes, materials and procedures are introduced.

You can prevent liabilities as a result of your uncontrolled environmental impacts. Pre-empt the potential issues by conducting an environmental impact assessment (EIA) to minimise environmental damage. Our assessment of your proposed project will inform your decision makers of the likely impacts so that potentially adverse situations can be addressed before a project is implemented.

In line with the mission of the OHSA (Occupational Health & Safety Authority) we endeavour to help you create a working environment in order ‘to ensure healthier and safer work places in Malta.’ (OHSA website; 2016)

Our advisory services vary from basic health & safety audits, risk assessments and inspections to fully fledged Management Systems encompassing the entire business processes and providing a globally accepted framework based on OHSAS 18001 (planned to be replaced by ISO 45001 by December 2017).