By: Supriya Sharma, Shamita Kohli
Poona College of Pharmacy, Bharati Vidyapeeth University, Pune
The quality of finished products solely depends upon the quality inputs & hence material management becomes very important activity in pharmaceutical manufacturing operations. The total material management activity starts right from selection of vendors for raw material, packaging material to dispatch of finished product to its destination. All materials & products should be stored under appropriate conditions in orderly fashion to permit batch segregation & stock rotations by first in first out & first expiry first out.All materials should be purchased against an approved & adequate specification which defines not only the grade & quality required but also the nature of packaging containers to be used. The quality material should clearly specify important pharmacoepial specifications & characters. Materials should be purchased only from approved supplier or manufacturer. Raw material & packaging material should be purchased by trained buyers by preferably material managers who has sufficient exposure of raw material & packaging material.All the raw materials should be checked after receiving for the name of manufacturer, batch no., date of manufacture, date of expiry etc.Records for receipt of material e.g. bills, customs etc. should be available. There should be special sampling booths & identified Quality control person for sampling of receiving materials. Material in the storage area should be appropriately labeled. Containers from which samples have been taken out should be identified. Only materials released by quality control department & with in there shelf life should be used. There should be SOP/R on sampling, storage & dispensing of material.There should be a classified list of approved vendors along with name of the packaging material. e.g. primary, secondary, printed packaging material. Printed packaging material should be stored securely in lock & key system. SOP/R should be available for dispensing of packaging material. There should be registers for sampling & dispensing of packaging material in chronological order. Out dated or obsolete packaging material should be destroyed by suitable approved method under the supervision of quality assurance person. Access to the storage area should be limited to the authorized person only. A list of material is based on storage material to be available.The storage of intermediate & bulk product is the responsibilities of production department. These products should be stored under appropriate storage conditions & the bulk products which are purchased as such should be handled on receipt as though they were raw materials.These products should be held in quarantine until their final release. Each batch of finished product should be tested as per laid down testing procedures & then only released for distribution. Products failing to meet established specifications should be rejected. If feasible reprocessing is performed. SOP/R for release & reprocessing should be available.Rejected & recovered material can be reprocessed & retested to see whether it meets our specific requirements or can be destroyed or has to be sent to the supplier. Such material should be clearly marked & stored in restricted areas which are normally painted red in color.
Reprocessing should be permitted only if the resulting batch is going to meet the specifications. The addition of recovered product should be authorized before hand & after the addition of recovered or reprocessed product to the batch. Additional testing of finished product should be done. SOP/R on handling & disposal of rejected & recovered material should be available.
Products which are already distributed or sold may be required at times to be recalled for various reasons e.g. substandard quality, damage of goods during transit etc. such recalled product should be clearly identified & stored separately until a decision is taken on there fate. SOP/R on handling of recall product should be there.Pharmaceutical products can be returned from market for various reasons e.g. quality problems, accidental damage of goods etc. such product should be physically examined & evaluated for quality. if possible reprocessing & releasing is done otherwise the product is destroyed. SOP/R on handling of returned goods should be available.A register of reagent & culture media should be maintained. Reagents should be prepared according to SOP’s both positive & negative control should be applied to verify the suitability of culture media.Pharmaceutical manufacturing operations generate a lot of waste materials. Provisions should be made for proper & safe storage of disposal of waste materials. SOP/R of handling of waste material should be available.Reference standards should be prepared by using a defined procedures & to be tested, released & then stored in the same way as official standard under the responsibility of designated person in secured area. SOP/R on handling of reference & working standard should be available.