Regulatory Guidelines

Regulatory Guidelines

· ISO Guidelines

· WHO Guidelines

· US-FDA Guidelines

· ICH Guidelines

· MHRA-UK Guidelines

· MCC Guidelines -South Africa

· TGA Guidelines-Australia

· MCA
Guidelines-Zimbabwe

· Schedule M-India

· European Guidelines

· MEDSAFE Guidelines -Newzeland

· GCC Guidelines -Gulf

· PDMA Guidelines -Japan

· PANDRH Guidelines -American

· PIC/S Guidelines

· IPEQ Guidelines

· Drugs & Cosmetics Act-India

· APIC
Guidelines

· EU
Guidelines

 

ICH Guidelines

ICH Guidelines

International Conference
on Harmonisation (ICH) is a commety that
provides the pharmaceutical guidelines for industries.

· Quality
Guidelines

· Efficacy
Guidelines



· Safety
Guidelines

· Multidisciplinary
Guidelines

 

WHO Guidelines

WHO Guidelines

World health organization (WHO) provide
the GMP guidelines for pharmaceuticals. These guidelines are followed through
the world.

These guidelines cover all the pharmaceutical topics as:

1. Process validation

2. Cleaning validation

3. Analytical method validation

4. DQ, IQ, OQ, PQ of equipments

5. Water system validation

6. HVAC validation

7. Computer system validation

8. Market complaint handling

9. Product recalls

10 Stability studies and may more...



Following are the general guidelines of WHO.

· General

· Volume 2, 2nd
updated edition













WHO guidelines for Active Pharmaceutical Ingredients

· API  









New TRS





WHO Technical Report Series
961, 2011

44th report

English

WHO
Technical Report Series 957, 2010

43rd report

• English
  
  pdf, 999kb
  
  WHO Technical Report
  Series 953, 2009

42nd report

• English
  
  pdf, 593kb
  
  WHO Technical Report
  Series 948, 2008

41st report

• English
  
  pdf, 1.22Mb
  
  WHO Technical Report
  Series 943, 2007

40th report

WHO
Technical Report Series 937, 2006

• English [pdf 2.08Mb]

39th report

WHO
Technical Report Series 929, 2005

• English [1.21Mb]

38th report

WHO
Technical Report Series 917, 2003

• English [pdf 386kb]

37th report

WHO
Technical Report Series 908, 2003

• English [pdf 632kb]

36th report

WHO
Technical Report Series 902, 2002

• English [pdf 1Mb]

35th report

WHO
Technical Report Series 885, 1999

• English [pdf 7Mb]

34th report

WHO
Technical Report Series 863, 1996

• English
  Part 1 [pdf 3.8Mb] 
• English
  Part 2 [pdf 4Mb]

33rd report

WHO
Technical Report Series 834, 1993

• English [pdf 1.5Mb]

32nd report

WHO
Technical Report Series 823, 1992

• English [pdf 6.4Mb] 

 

· Risk
analysis

· Training
materials

· An
introduction, resource and study pack for trainers

· Blood and
Biological Products

· Radio
Pharmaceuticals

· Further
References









Also Read:

· ISO Guidelines

· US-FDA Guidelines

· ICH Guidelines

· MHRA-UK Guidelines

· MCC Guidelines -South Africa

· TGA Guidelines-Australia

· MCA
Guidelines-Zimbabwe

· Schedule M-India

Validation

Non-sterile
process validation

Cleaning
Validation 

Qualification
of systems and equipment

 

Procedure for change control in pharmaceuticals

Procedure for change control in pharmaceuticals

1.0         Purpose:

To
describe a procedure for change control.

2.0         Scope:

This
SOP shall be applicable for the identification, documentation, appropriate
review and approval of changes in raw materials, specifications, analytical
methods, facilities, support systems, equipment (including computer hardware)
processing steps, labeling and packaging materials, and computer software.

3.0         Responsibility:

Designee of Originating
Department:         

4.0         Procedure:

1.          The
initiating department shall initiate the change as per the change control
format no.

2.          The
initiating department shall furnish the details very clearly in the form for
present process/use, proposed change, Justification & impact analysis and
acceptance criteria.

3.          The
initiating department shall also define changes as major or minor based on
product quality or its impact of safety, health and environmental aspects. Some
of the major and minor changes are listed below: -

3.1       
Major Changes

For a substance of
chemical and microbiological quality evaluation.

•         Addition or
deletion of a step or addition of an alternative/new step in the formulation
manufacturing process.

•         Addition of a new
manufacturing site with modification of the formulation manufacturing process
described in the original dossier/document.

•         Change in input
quantities of formulation manufacturing process.

•         Changes in the
quality of raw material(s) or key intermediate(s) used in the formulation
manufacturing process.

 

3.2.   
Minor Changes

•        
Change in the administrative references (name/company name, address) of the
certificate holder.

•         Change in the
references (name/company name, address) of the manufacturing site.

•         Change or updating
of the methods of analysis used to test the substance.

•         Change in the
specifications of the substance.

•         Change in supplier
of starting and packing material.

•         Change in the batch
size.

•         Addition of a
new manufacturing site in the same site as described in the original dossier.

•         Change in the
documents like SOPs etc.

4.          The
Initiating department shall forward the proposal as per the requirement
to Formulation & Development Department for comments and clearance.

5.          After
giving comments/clearance, Formulation & Development shall forward the
change control form to Quality assurance department.

6.          On
receipt of Change control form from F & D department, QA shall assign the
Change control number as per the procedure given below:

                      Assigning
a change control number

      Each change
control number contains seven digits.

-     First two digits
represents change control code.

-     Third, forth and
fifth digit represent sequential change control No. (001 to 999)

-     Sixth and seventh
digit represents last two digits of the current year. (e.g.01,
02, 03…...99).

For
example, following change control no is decoded as explained.

CC-001/ 03.

CC = Change control code.

001=
Sequential Change control Number (001, 002, 003…………..999). 

03=
Current year 2003 (Last two digit of current year)

 

7.          QA
shall enter the details of Change in the Change control register.

8.          QA
shall evaluate the feasibility of the change and forward the change control
form to Regulatory affairs, if required.

9.          Regulatory
affairs shall evaluate the change in terms of any need to inform customer or
any updation in dossiers etc. and forward the change
to Site Quality Head.

10.      Site
Quality Head shall receive the comment form all the concerns and takes the
decision of approving or rejecting the change.

11.      On
completion of the total procedure, QA shall formally enter the status in Change
control Register and close the Change control Procedure.

12.      Put the
stamp of ‘OBSOLATE COPY’ on the old documents, where every this change control
procedure is applicable.

 

5.0      

Revision Log:

 

Revision No.	Effective Date	Reason
01	15.04.05	Format Changed

  
        

6.0                    Abbreviations:

Abbreviation	Expanded Form
QA	Quality Assurance
VP	Vice President
SOP	Standard Operating Procedure
F & D	Formulation & Development

7.0         

Annexure:

              
Annexure-1:      Change Control Form

 

 

       
                                                              Annexure-1

                                                              
Change Control Form

1.	Initiating Dept
	Change Control No.
	Stage/Document
	Manufacturing Date
	Implementation Date
2.	Present Process/Use*	Modification: Major/Minor
3.	Proposed Process/Use*
4.	Justification/Impact of Change*
5.	Supporting Data(If Required)	Enclosed/Not Enclosed
6.	Accepted Crieteria
7.	Signature: ________________                          ___________________                        (Officer/Executive/Designee)            (Head – Initiating Department)                    Date: _________________                         ____________________

 

8.	Comments from F&D Department*(if required)
				Modification:	Major/Minor
				Date:
	Signature	Manager-F&D
9.	Comments from Quality Assurance Department*
				Modification:	Major/Minor
	Regulatory Notification / approval			Required / Not Required
	Type of analysis to be carried out (if any extra analysis is required, give details):
	Subsequent Stages	Will be controlled/Not controlled
	Validation Status	Will affected / not affected
				Date:
	Signature	Manager - QA
10.	Comments from Regulatory Affairs Department*(if required)
	Proposed Change is recommended/ Not recommended
				Date:
	Signature	Manager – RA
11.	Comments from Engineering Department* (If required)
				Date:
	Signature	Manager - Engineering
12.	Comments
				Authorised / Not authorised
				Date:
	Signature:     Plant Head		Site Quality Head
*Whenever applicable, append supporting documentation.

                                                                      

  

 

Change Control Record

 

S.N	Date	Change Control no.	Originating Dept	Product / Document	Stage	Details of Change	Date of Implementation	Status	Remarks