PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: Legal and Other Requirements
Department: SH
SOP No.:
Effective Date: 25/08/16
Revision No.: 01 Revision Date: 24/08/18
Supersede Revision No.: 00 Page No.: 1 of 6
1.0 OBJECTIVE:
To lay down a procedure for Legal and Other Requirements.
2.0 SCOPE:
This SOP is applicable for the all Environmental Legislative Laws, Regulations and Policies relevant to
products, activities and services at …………….
3.0 RESPONSIBILITY:
Officer / Executive - EHS
4.0 ACCOUNTABILITY:
Head – EHS
5.0 PROCEDURE:
5.1 IDENTIFICATION:
5.1.1 EMS core team shall obtain copies of Acts/Rules/Notification from all related agencies, internet
or any other source.
5.1.1.1 Regulatory websites.
5.1.1.2 Corporate Legal Cell.
5.1.1.3 Any other source.
5.1.2 Review the regulatory & legislative requirements, identify those relevant and applicable to our
operations and include in Annexure-I, Titled “List of Applicable Acts/Rules”. Remarks to be
mentioned to inform any special case of act/legislation.
5.1.3 Disseminate and communicate the information to relevant agencies including justification for its
applicability; and sharing the changes in review meetings.
5.1.4 If applicable to our operations then interact with concerned personnel, and review existing data.
Action plans (EMP / HMP / OCP) to ensure compliance in given time frame if not doing so and
act to Revise Aspect / hazard register if required as per new /revised requirements.
5.1.5 Make a new legal register in case of new regulation or Update the existing register whenever
there is any change/updation of relevant Acts/Rules /Regulations/terms of permits/consent and
applicable company targets/threshold limits.
5.1.6 Observations of any legal authority during plant inspection/visits shall be communicated to all
concerned including unit Head EHS and Plant/Functional heads will ensure that all observations
are complied. The legal authorities may include:
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: Legal and Other Requirements
Department: SH
SOP No.:
Effective Date: 25/08/16
Revision No.: 01 Revision Date: 24/08/18
Supersede Revision No.: 00 Page No.: 2 of 6
5.1.6.1 Factory Inspectorate.
5.1.6.2 Electrical Inspectorate.
5.1.6.3 Inspection by Explosives Department.
5.1.6.4 MOEF/PCB Authorities.
5.1.6.5 Ground water Authorities.
5.1.6.6 Any other consultant etc.
5.2 ACCESS:
5.2.1 Original copy of LOR shall be maintained by HR Department.
5.2.2 Reference copy will be disseminated through e-mail or electronic file by EMS LOR coordinator
to reduce papers, energy and other printing materials.
5.2.3 Any controlled copies shall be requested from QA department.
5.3 EVALUATION OF COMPLIANCE:
5.3.1 EHS Departments will check compliance with LOR and the level of such compliance will be
indicated in the LOR Matrix as per Annexure-II.
5.3.2 Use external agencies for testing of conditions with known Legal standard as appropriate.
5.3.3 LOR shall be periodically checked for compliance, as a minimum, shall do it yearly.
5.3.4 Lists of LOR with due dates may be used to check if all requirements are met based on the set
deadlines and regulations.
5.4 NON-COMPLIANCE:
5.4.1 Re-test shall be done and Corrective Action will be taken for Minor Non-Compliance.
5.4.2 For Major and continuous Non-conformance, it shall be considered in setting the Objectives and
Targets.
5.5 PERIODIC CHECK FOR NEW, REVISED LEGAL AND OTHER REQUIREMENTS:
5.5.1 To update LOR Matrix, EHS or any designated persons by the EMR shall regularly check for
new revisions of existing LOR. EHS shall do it once a year.
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: Legal and Other Requirements
Department: SH
SOP No.:
Effective Date: 25/08/16
Revision No.: 01 Revision Date: 24/08/18
Supersede Revision No.: 00 Page No.: 3 of 6
5.5.2 In the event of major changes in the interim, LOR shall be updated.
5.5.3 EHS may approach any of the following for access to new/revised regulations:
a. Directly to the agency
b. Newspapers
c. Consultants
d. Websites
5.5.4 EHS will review and check if the new or revised LOR are applicable. If applicable, requirements
will be reviewed and cascaded by EHS for implementation and compliance.
5.6 INFORMATION DISSEMINATION
5.6.1 Information regarding LOR shall be disseminated to all affected Departments through Electronic
files.
6.0 REFERENCES:
6.1 ISO 14001:2004 Environmental Management System (EMS)–Requirements with guidance for use.
6.2 Environmental Protection Act 1986 & Uttar Pradesh Factory Act
7.0 ANNEXURES:
ANNEXURE No. TITLE OF ANNEXURE FORMAT No.
Annexure-I List of Applicable Acts/Rules
Annexure-II Legal and Other Requirements Matrix
ENCLOSURES: SOP Training Record
8.0 DISTRIBUTION:
Controlled Copy No.1 Head EHS
Master Copy Quality Assurance Department
9.0 ABBREVIATIONS:
SOP Standard Operating Procedure
Ltd Limited
No. Number
EMS Environmental Management System
EMR Environmental Management Review
IER Initial Environmental Review
LOR Legal & Other Requirements
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: Legal and Other Requirements
Department: SH
SOP No.:
Effective Date: 25/08/16
Revision No.: 01 Revision Date: 24/08/18
Supersede Revision No.: 00 Page No.: 4 of 6
10.0 REVISION HISTORY:
CHANGE HISTORY LOG
Revision No. Details of Changes Reason for Change Effective Date Updated By
Introduction of New
00 New SOP
SOP
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: Legal and Other Requirements
Department: SH
SOP No.:
Effective Date: 25/08/16
Revision No.: 01 Revision Date: 24/08/18
Supersede Revision No.: 00 Page No.: 5 of 6
ANNEXURE – I
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
LIST OF APPLICABLE ACT / RULES
S.No. Act/Rules Remarks
1. The Factories Act, 1948
2. The Indian Electricity Rules ,1956
3. The Environmental (Protection) Act, 1986, Rules 1986
4. The Water (Prevention & Control of Pollution) Act 1981
5. The Air (Prevention & Control of Pollution) Act 1981
6. Noise Pollution (Regulation and Controls) Rules 2000
7. Ozone Depleting Substances Rules,2000
8. Indian Explosives Act 1884, Petroleum Act 1934 and Rule 1970
9. The Static Mobile Pressure Vessels(Unfired) Rules,1981
10. Central Motor Vehicle Rules,1989
11. Gas Cylinder Rules.1981
12. The Batteries(Management & Handling) Rules 2001
13. The Public Liability Insurance Act 1990 and Rules 1991
14. The MSI of Hazardous Chemical Rules, 1989
15. The Hazardous Wastes (Management & Handling) Rules, 1989
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: Legal and Other Requirements
Department: SH
SOP No.:
Effective Date: 25/08/16
Revision No.: 01 Revision Date: 24/08/18
Supersede Revision No.: 00 Page No.: 6 of 6
ANNEXURE – II
PHARMA DEVILS
ENVIRONMENT HEALTH SAFETY DEPARTMENT
LEGAL AND OTHER REQUIREMENTS MATRIX
Act / Procedural Activities Reference Remarks Objective
Applicability Frequency Status
Rules Requirements to be done Documents if any Evidences
