abhishreshthaa
Abhijeet S
PHARMALINK has a written "Quality Manual" which gives details of the principles, objectives, responsibilities and function of the Quality Control (Q.C.) and Quality Assurance (Q.A.) Departments. With a view that Quality is built into products, the company has a detailed Quality System implemented by the qualified staff and where required, staff approved by Food & Drug Administration authorities.
The function of the Quality Assurance Department is also to evolve, standardize and validate Quality system that encompasses all the activities involved in the manufacturing and testing of all the products at whichever stage necessary.
The Quality Control Department follows approved and validated methods to sample and test raw material and packing material, in-process material and finished goods and is equipped with sophisticated instruments e.g. and visible spectrophotometer and microbiological testing laboratory. In addition to this wherever required the help of approved public testing laboratories is also taken.
The Quality Management System included written procedures for all activities as “Standard Operating Procedures." The documentation system also includes Master Formula Record for each product, Batch Manufacturing Record for each batch, standard specification and standard testing procedures.
The equipment used and processes followed for production, and the instruments used in testing are validated following a written protocol and data and result of the same are meticulously recorded and maintained. The specification for raw material, in-process and finished goods are laid down with upper, lower and acceptance levels of limits.
The technical personnel in the company undergo regular in house training for their upgradation. This training comprises of a series of lectures on different relevant subjects by experts.
Thus the objective of this system of every activity being carried out by validated, written procedures under supervision of qualified, trained, experienced and motivated personnel is achieved.
The function of the Quality Assurance Department is also to evolve, standardize and validate Quality system that encompasses all the activities involved in the manufacturing and testing of all the products at whichever stage necessary.
The Quality Control Department follows approved and validated methods to sample and test raw material and packing material, in-process material and finished goods and is equipped with sophisticated instruments e.g. and visible spectrophotometer and microbiological testing laboratory. In addition to this wherever required the help of approved public testing laboratories is also taken.
The Quality Management System included written procedures for all activities as “Standard Operating Procedures." The documentation system also includes Master Formula Record for each product, Batch Manufacturing Record for each batch, standard specification and standard testing procedures.
The equipment used and processes followed for production, and the instruments used in testing are validated following a written protocol and data and result of the same are meticulously recorded and maintained. The specification for raw material, in-process and finished goods are laid down with upper, lower and acceptance levels of limits.
The technical personnel in the company undergo regular in house training for their upgradation. This training comprises of a series of lectures on different relevant subjects by experts.
Thus the objective of this system of every activity being carried out by validated, written procedures under supervision of qualified, trained, experienced and motivated personnel is achieved.