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Friday, 30 December 2011



The basic elements of the quality management are :
Quality Assurance
Organizational structure,
Quality assurance . . .
  Q.A a wide ranging concept which covers all matters which individually or collectively influence the quality of product

The system of quality assurance should ensure  . . .
Pharmaceutical product are designed and developed in a way that takes account of the requirment of GMP
Production n control operation are clearly
Managerial responsibilities
All necessary controls on intermediate product and in-process controls n validation
Regular evaluations of the quality
The basic requirments of GMP
All manufacturing processes are clearly n systematically
All necessary facilities
Operator are trained to carry out procedures correctly
A system is available to recall any batch of product
Records of manufacture
Critical steps of manufacturing
Necessary Facilities
The head of production
The head of quality control
The head of quality management

The basic requirments

Premises must be located, designed, adapted and maintained to facilitate proper operations.
Their layout and design must airn to minimize risk or confusion, and other error.
Premises should be carrefully maintained.
They should be cleaned and disinfected according to detailed written procedures.
Lectrical supply, lightng, temperature, humidity, and ventilation shoud be appropriate.

Safe and secure areas
*highly active materials
*radioactive matrials
*other dangerous drugs and substances presenting special risks of abuse, fire or explosion.

Design and construction...
Equipment surfaces coming into contact with any starting material, intermediate, bulk or finished product shouldnot be reactive, additive, or absorptive
Equipment shouldnot adversely affect the product
Equipment should be designed so that it can be easily and thoroughly cleaned
Balances and measuring equipment of an appropriate range and precision should be available for production and control operations.
Installation and location
Equipment should be maintained at appropriate intervals to prevent malfunctions or contaminations which could alter the identity, quality, or purity of the product.
Written procedures should be established and followed for maintenance of equipment.

The scope of sanitation
In manufacturing areas should wear protective garments appropriate to the operations to be carried out.
They should wear clean body-coverings appropriate to the duties they perform.
}Detailed hygiene programmes should be established.
}All personnel should receive medical examination upon recruitment.
}They should be trained in the practices of personal hygiene.

Premises sanitation
Adequate employee’s washing and well ventilatedtoilet facilitiesshould be provided
Waste material should not be allowed to accumulate.
There should be written procedures for use of suitable rodenticides, fungicides, clening, and sanitazing agents.
Equipment cleaning and sanitation
Equipmet should be cleaned both inside and ouside after use according to established procedure and should be kept in a clean condition.
Vacuum or wet cleaning methods are to be preferred.
Record of cleaning, sanitazing, sterilization and inspection prior to use should be kept properly.

  production operations must follow clearly defined procedures (GMP)

Production should be performed and supervised by competent people.
All incoming materials should be checked .
All materials and products should be stored under the appropriate condition established by the manufacturer.
Labels applied to containers, equipment or premises should be clear, umambiguous.
Prevention of cross-contamination in production
Production in separate building (penicillin, sex hormones, certain cytotoxic, live vaccines, live bacterial preparation, etc)
Poviding appropriate air-locks and air extraction
Keeping protective clothing
Using cleaning and decontamination procedures
Using self contained system
Production in separate building
*sex hormones
*certain cytotoxic
*live vaccines
*live bacterial preparation
All materals utilized in processing should be checked before use.
All operations should be prformed in accordance with the written procedures.
Any deviation should be justified and reported.
Containers and closures used should be clean
All required in-process controls should be accurately.
In-process control...
All parameter attributes, product fill or count should be cheked
Finished packages should be checked
Results of in process test/inspection should be recorded and those documents should become a part of the batchrecord.
Rejected, recovered and returned materials
Rejected materials and products should be clearly marked as such and stored separately in restricted areas.
Products returned from the market and which have left the control of the manufacturer should be destroyed.
Any action taken should be appropriately recorded.
Process validation
When any master processing procedure is adopted, steps should be taken to demonstrate that it is suitable for routine operation.
Processes and procedures should undergoperiodic critical revalidation.
Stability study
All starting materials, packaging materials, intermediate and bulk product returned to storage areas should be properly documented and reconciled.

Quality control is..
 An essential part of Good Manufacturing Practices to provide assurance that the products will be consistently of a quality appropriate to their intended use.
Each holder of a manufacturing authorization should have a quality control department.
Quality control should involve all analytical functions conducted in the laboratory, including sampling, inspecting and testing of starting material, intermediate, bulk, and finished products.
Principal duties....
To establish and revise control procedures and spesifications.
To prepared detailed written instructions for carrying out each inspection,test and analysis.
To establish written sampling plans and sampling procedures.
To ensure the correct labelling of containers of materials and products.
To release or reject each batch or starting material intermediate, bulk, or finished products.
To take part or assist in validation program
To prepare secondary reference standars
To maintain analytical records of the tests of all samples taken.
Good Quality Control Laboratory practices
ØProvisions should be made for the proper and safe storage of waste materials awaiting disposal.
ØThe laboratories should be physiccaly separated from the production rooms.
ØBiological, microbiological, and chemical laboratories should be segregated from each other.

ØShould have proper education,trining and experienceor comination thereof, to enable the individualto perform the assigned functions.
ØControl laboratory aquipment and instruments should be suitable to the testing rpocedures undertaken.

The written program should be followed and include ;
Sample size, test interval
Storage conditions
Reliable, meaningful, and spesific test method
Testing of the product for reconstitution before and after it has been reconstituted.

List for self inspection....
¡Maintenance of buliding n equipment
¡Storage of starting materials, packaging materials, and finished products
¡Productions ana in- process control
¡Quality control
¡Sanitation n hygiene

Management should appoint a team of self inspection consisting af at least three members who are experts in their own fields and familiar with GMP
¡Self inspection report
A list of approved suppliers of starting n packaging materials should be established n reviewed.
Before suppliers are approved n included in the approved suppliers list or specifications, they shoud be evaluated.

A product recall is ....
  instituted following discovery  of a quality defect or if there is a raport of serious adverse reaction of a pharmaceutical product which may cause health risk.
A returned pharmaceutical products is
  a finished product which is already in distribution and returned to the manufacturer due to complain of damage , expiration or other reasons such as the condition of the container or package which may cast doubt on the product identity, quality, quantity, and safety.
Each complaint and report should be thoroughly investigated n evaluated
including :
The Action
Recall of the batch or all the finished products
Other appropriate action
Corrective action where applicable
There should be established written procedures, regularly checked and updated when necessary, in order to organise any recall activity.
A product recall should be instituted immediately after discovery of a quality defect or receiving report of adverse reaction of the product.
Decision for recall a product
May be initiated by the manufacturing or under instruction of the government authority
From the head of Quality Management n the company management
May result in suspension or discontinuation of manufacturing of the products
Documents should have unambiguous contents, title, nature n purpose should be clearly stated
Reproduced document should be clear and legible
Any alteration made to the entry on a document should be signed and dated , the alteration should permit the reading of the originil the information. 
Documents Required
¡The name of material on the delivery nnote and containers
¡Code of material
¡Date of receipt
¡Supplier’s name
¡Manufacturer’s batch
¡Total quantity and number of containers receivedthe batch number assigned after receipt
There must be written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party.
There should be a written contract covering the manufacture and/or analysis arranged under contract and any technical arrangements made in connection with it.
The Contract Giver
  Should provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the marketing authorization and any other legal requirements.
The contract acceptor
The contract acceptor should refrain from any activity which may adversely affect the quality of the product manufactured and/or analyzed for the contract giver.
The contract acceptor must have....
A contract should drawn up between the contract giver and the contract acceptor which specifies their respective responsibilities relating to the manufacture and control of the products.
The contract should describe the handling of stating materials, intermediate and bulk products and finished products if they are rejected.
Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results
Action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results
(Validation usually incorporates the concept of qualification)
lEssential part of GMP
lManufacturer to identify what qualification and validation work is required
lProve that critical aspects of work are controlled
lKey elements of qualification and validation defined and documented
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Process Validation (PV)

Qualification and validation:
lApplicable to any aspect of operation which may affect the quality of the product
äDirectly or indirectly
lIncludes premises, facilities (utilities), equipment, processes
lIncludes significant changes
lQualification and validation should be done in accordance with an ongoing programme
äInitial qualification and validation
äAnnual review
lMaintain continued validation status
lPolicy described in relevant documentation, e.g. quality manual, or Validation Master Plan

Types of Documentation
lValidation Master Plan (VMP)
lValidation protocols
lValidation reports
lStandard Operating Procedures (SOPs)
lClearly defines responsibility of performing validation
lConducted in accordance with predefined, approved validation protocols
lRecorded results and conclusions presented in written validation reports – prepared and stored
lProcesses and procedures should be established on the basis of these results

lPremises, utilities, equipment and processes
lCritical importance and particular attention paid to validation of:
äAnalytical test methods
äAutomated systems
äCleaning procedures

Example of priorities for process validation
  Type of process       Requirement 
lNew       Every new process before approval for routine
äSterile products     All processes affecting the sterility, and
                                 manufacturing environment including
                                 sterilization stage
äNon-sterile      Low dose tablets and capsules: mixing and
                                 granulation; content uniformity (and other
     Other tablets and capsules: uniformity of  mass
                                (and other parameters)

The Validation Master Plan may contain elements (and policy) such as:
äApproval page and table of contents
äIntroduction and objectives
äFacility and process description
äPersonnel, planning and scheduling
äResponsibilities of validation team members
äProcess control aspects
äEquipment, apparatus, processes and systems qualified, validated – and to be qualified or validated
äAcceptance criteria
äDocumentation, e.g.validation protocols and reports
äTraining requirements and other elements…
A qualification or validation protocol may contain:
äObjectives of the validation and qualification study
äSite of the study
äResponsible personnel
äDescription of the equipment
äCriteria for the relevant products and processes

A qualification or validation report should reflect the elements of the protocol, and may contain elements such as:
äObjective of the study
äReference to the protocol
äDetails of materials, equipment, instruments, personnel
äProgrammes and cycles used
äDetails of procedure and test methods


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