cGMP and Regulatory Updates

1.0       OBJECTIVE This policy described the framework within which the Quality of HAPL products will be assured. 2.0       SCOPE This  policy  is  applicable  to  HAPL facilities including R and D Production and Distribution. 3.0       GUIDEDENCES/DIRECTIVES/REGULATIONS 3.1        The local Health Authority Guidelines/Directives/Regulations should be the basis for the development of Quality Guidelines/   Procedures.   The HAPL Quality Policiese are written based on á realistic interpretation of international regulation. These standards will be interpreted though Policies   Guidelines ánd Procedures. 3.2        The policies that are developed by QÁ should be translated, using common   sense   and   appropriate local   management   review,   into pracival procedures (S...

The following is the manner in which various departments send an intimation to Q.C. when any analysis is required. a)          When a consignment of raw materials is received by Stores, intimation is sent to Quality Control Department on a Goods Received   (G.R.)   Note b)          Whenever manufacture of any bulk drug or formulation is   complete, ‘Test Request’ (T.R.) Forms are sent by Production Departments to the Quality Control Department as an intimation for sampling. c)          The Production Department for all intermediates and in-process samples sends technical Information T.I. sheets Samples are sent by the Production Department   alongwith the T.I. sheets. 1                     After receiving the G.R. notes/T.R. forms/T.I. sheets, make entries in the releva...

1.0 Any deviation in manufacturing process shall be performed as per the following. If deviation is not approved, the batch shall be disposed off. DEVIATION APPROVAL FORM Item : ________________ Request No : ________ Quantity : ________________ Date : ____________ Value (Rs.) : _____________________________________ Originating Department : _____________________________________ Description of Non-Conformance : _____________________________________ Reasons for Deviation : _____________________________________ Recommended Disposition : _____________________________________ Corrective Action : _____________________________________ APPROVALS : Department/ Acceptance of Deviation /Signature / Date Purchase / Yes / No Quality Assurance / Yes / No Research & Development / Yes / No Marketing / Yes / No Manufacturing / Yes / No Disposal Action Initiated by : ________________ Date : ________________ Corrective Action Initiated by : _____________...