Doc No : RP-SP/F-11

Issue No: 01
Issue Date: 11-10-2012

Intent

LEGAL AND OTHER REQUIREMENT

Relevant legal and other requirements related to Environment are identified,

understood and complied with as a minimum.
Performance Requirements
Ray Pharma shall establish and maintain Management systems to identify all
applicable Environment related laws, regulations, licenses, permits, and other
requirements (i.e.: codes, charter, standards, etc) and shall incorporate these into a
Ray Pharma Integrated QEHS Management system. The system shall be updated to
reflect changes to these requirements.
The implications of these requirements shall be assessed, and systems established
and maintained to ensure compliance. Due diligence shall be demonstrated through
effective communication of specific requirements, monitoring, record-keeping and
reporting.
Responsibility
Quality Control Manager / Management Representative is responsible to seek
regular updates from the local associations i.e. EPA, BLP and assess the impact of
new regulations, communicate to concerned area and update the QEMS system
accordingly.
Procedure
1. QCM/MR will contact the following bodies on yearly basis to identify any changes
in regulatory requirements.
1.1.Sindh EPA
1.2.BLP
1.3.Civil Defense Department
2. In case if any new requirements are communicated by the regulatory bodies or
identified by Ray Pharma itself, they are discussed in System Review Meetings.
3. Before the System Review meetings, QCM/MR will email/ circulate the
new/amended requirements to concerned functions.
4. The following parameters are considered w.r.t new or amended regulatory
requirements.
4.1. Interpretation of requirements
4.2. Implication of requirements for Ray Pharma
4.3. Time frame from regulatory bodies for implementation/compliance
4.4. Any changes in documented system
4.5. Any resource requirements for implementation/compliance

5. Relevant functions e.g. Production, Maintenance, Quality, Finance, Administration

etc will provide its feedback during the System Review meetings.
6. In case if it is decided that the new/amended regulations will be implemented,
QCM/MR will develop the action plan for the implementation. The format of
Objective action plan can be used for this purpose as well.
6.1.In case of any changes in the documented system as a part of regulatory
compliance, QCM/MR or concerned department will update the documented
system and communicate the revised documents to concerned functions
accordingly.
7. QCM/MR will maintain the Master List of Applicable Regulatory Laws and
Legislations to reflect the current applicable legislations.
Supporting Documents
Master List of Laws and Legislations

Doc No : RP-SP/F-11
Issue No: 01
Issue Date: 11-10-2012

_____________
Reviewed By

____________
Approved By