Study Set Content:
A() should be developed, established and implemented as a means by which stated policies and objectives will be achieved
quality system
It should define the organizational structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management.
quality management system
he quality system should be structured and () to the company’s activities and to the nature of its products and should take into consideration appropriate elements stated in this Guidelines.
adapted
The quality system operation should ensure that if necessary, samples of starting materials, intermediate, and finished products are taken, tested to determine their release or rejection on the basis of test results and other available evidence related to ().
quality
QUALITY MANAGEMENT SYSTEM
PERSONNEL ¨ Organization, Qualification and Responsibilities ¨ Training ¨ Premises ¨ Equipment and Apparatus
¨ Equipment and Apparatus
o Design and Construction Maintenance o Installation and Location
Sanitation and Hygiene
Clean drinking water, toilet with sceptic tank, Handwashing with soap
PRODUCTION
Starting Materials ¨
Batch Numbering System
¨ Weighing and Measurement
¨ Procedure and Processing
¨ Dry Products
¨ Wet Products
¨ Labelling and Packaging ¨
Finished Product:
Finished product
Quarantine and Delivery to Finished Stock
s an essential part of GMP. It provides assurance that cosmetic products will be of consistent quality appropriate to their intended use.
Quality control
should be established to ensure that products contain the correct materials of specified quality and quantity and are manufactured under proper conditions according to standard operating procedures.
quality control system
should be evaluated to ensure that they do not affect the quality of the product.
REPROCESSING
should be identified and stored separately either in allocated area or by moveable barrier such as rope or tape.
RETURNED PRODUCTS
All returned products should be tested if necessary, in addition to physical evaluation before being released for().
distribution
should include the complete history of each batch, from starting materials to finished products. The system should record executed activities for maintenance, storage, quality control, primary distribution and other specific matters related to GMP.
DOCUMENTATION
Raw and packaging material specifications should include:
(a) () of material (b) () of the material (c) Testing ()(and) limits (d) Technical (), where applicable. (e) () precautions e.g., storage and safety conditions, if necessary
Name, Description, parameters and acceptance drawings, Special
Bulk and finished product specifications should include:
a) () of product (b) Description (c) () properties (d) ()assay and/or microbiological assays and their acceptance limits; if necessary (e) () conditions and safety precautions, if necessary
Name, Physical, Chemical , Storage
The Master formula should be available upon request. This document should contain the following information:
(a) Product (). (b) Intended packaging materials, and () conditions (c) List of () used (d) List of () used. (e) () controls with their limits in processing and packaging, where applicable.
name and product code/number, storage, raw materials, equipment, In-process
BMR should include the following: (i) ()of product (ii) () formula (iii) Brief () process (iv) ()() number (v) Date of the() and () of processing and packaging
Name , Batch, manufacturing, Batch or code, start, finish
(vi) () of individual major equipment and lines or location used (vii) Records of () of equipment used for processing as appropriate (viii)() control and laboratory results, such as pH and temperature test records (ix) () inspection records (x) Any () performed during various steps of processing (xi) Any () of specific failure or discrepancies
Identity, cleaning, In-process, Packaging line clearance, sampling, investigation
