5.1 Quality manual shall give an overview on entire quality system, its organizational structure, content.
5.2 Quality manual shall be prepared with the following contents, but not limited to.
5.2.1 The first page contains details of document, Document Name, Document Number, Organization Name and Logo.
5.2.2 Table of contents:
5.2.2.1 This page contains list of sections of the quality manual and the page number.
5.2.3 Approval:
5.2.3.1 This page shall contain signatures of the persons who have prepared, reviewed and approved the Quality manual along with Name, designation, signature and date.
5.2.4 Introduction:
5.2.4.1 This point shall contain, the introduction of organization and company address.
5.2.5 Scope:
5.2.5.1 This section describes the extent to which Quality manual is applicable.
5.2.6 Quality Policy:
5.2.6.1 This section describes about the organization overall approach for quality system.
5.2.7 Quality objectives Management commitment and responsibility:
5.2.7.1 This section shall contain, the approach to meet the commitment of Quality policy.
5.2.7.2 This section also contains the management commitment and responsibility with in the pharmaceutical quality system.
5.2.8 Structure of Documents:
5.2.8.1 This section shall contain brief description of about documents and level of documents are available in the plant.
5.2.9 Elements of Quality management:
5.2.9.1 Under this section the following points to be covered but not limited to,
5.2.9.1.1 Description about organization and personnel
5.2.9.1.2 Building and facility
5.2.9.1.3 Utilities
5.2.9.1.4 Equipments
5.2.9.1.5 Production and process control
5.2.9.1.6 Packing and labeling controls
5.2.9.1.7 Holding and distribution
5.2.9.1.8 Quality control
5.2.9.1.9 Records and reports
5.2.9.1.10 Returned and Retrieved drug products
5.2.9.1.11 Reserve Samples
5.2.9.1.12 Quality assurance
5.2.9.1.13 Internal quality audit
5.2.9.1.14 Stability program
5.2.9.1.15 Qualification and validation
5.2.9.1.16 Personnel Training
5.2.9.1.17 Change control system
5.2.9.1.18 Computer system
5.2.10 References:
5.2.10.1 This section describes about the reference documents related to the quality manual.
5.2.11 Abbreviations:
5.2.11.1 The abbreviations used in Quality manual shall be clarified under this heading.
5.2.12 List of Annexures:
5.2.12.1 This shall include list of Annexures attached to the Quality manual.
5.2.13 Revision History:
5.2.13.1 Under this section revision status of the Quality manual shall be mentioned.
5.3 Numbering system:
5.3.1 The numbering system for Quality Manual: This is an alphanumeric number. For example: XXXX/QM/001-00.
5.3.2 The first four characters “XXXX” represent Company name.
5.3.3 The next character ‘/’ used as a separator
5.3.4 The next two characters “QM” represents title of the documents “Quality Manual’’.
5.3.5 The next three characters “001” denotes document number,
5.3.6 The next character ‘-’ used as a separator
5.3.7 The next two numeric characters indicate the version number of the document starting from 00 and continuing serially in increments.
5.4 Review and Revision of Quality Manual:
5.4.1 The Quality Manual shall be reviewed once in two year or as and when required. The revision shall be initiated through change control.
5.4.2 All the changes made shall be entered in brief in the ‘Change History’ at end of the Quality manual. Change history shall indicate all the changes associated with each of the version.
5.5 Issuance and control of quality manual:
5.5.1 After approval of the quality manual by Plant Head and Head QA, The QA personnel put the effective date and master stamp in the quality manual.
5.5.2 QA shall take photo copy of master quality manual and put control copy stamp and then shall be issued to Head QA and Plant Head.