Requisitos funcionales

When I entered the premises of the manufacturing division, straight in front of my eyes at

the corner of the main entrance to the production area was a large TOPIC banner. Next to

it was the main notice board of the division. The first notice that caught my eyes was the

information about GMP (Good Manufacturing Practices) and why following these

practices was crucial to the success of the company. The notice board also contained

information about the daily production target and actual achievement, as well as the

activities of the various departments in the division. On my right was the entrance to the

production department, where an electronic board displayed the target for the month and

the amount that needed to be produced in order to reach the target. As I went along the

ground floor corridor, I saw that it was the practice of the departments to display outside

their offices information relevant to their function. For instance, the finance department

displayed its returns on equity, net profits, earnings before interest and taxes, as well as

sales figures, and the supply chain department displayed its production target and actual

It did not take me long to realise that the production target and GMP formed the basis of

most of the talk, both official and informal, in the manufacturing division. Information

about them was displayed everywhere. Most conversations were characterised by the

struggle to balance the GMP status with the production target, which was the primary

issue in the manufacturing division since non-compliance with GMP guidelines may have

threatened its existence; it was usually the main issue discussed in the production

meetings. For example, in the case of contaminated products, a thorough investigation

would have to be conducted, production ceased until the issues had been resolved and, in

certain cases, clearance from the Ministry of Health would have to be obtained before

continuing production. This would then affect the achievement of the production target,

with the eventual loss of revenue. Even during breakfast and lunch operators were

discussing what to expect at the end of the month, including the possibility that they

would have to work at weekends in order to meet the production target. The subsequent

paragraph provides some features of manufacturing operations and illustrates the

significance of GMP and the production target that shaped the practices in this division.

The production area comprised the manufacturing suite 1 area, the manufacturing suite 2

area and the liquid and cream area. The buildings were constructed mainly of brick wall

with epoxy paint and ceilings were usually made of gypsum board, the selection of the

material and the type of machines to be used having to comply with GMP requirements

based on the concept of “clean room”. The stringent requirements of GMP guidelines

known to be one of those that incur a high cost of compliance. It is subject to regular

audit from the National Pharmaceutical Control Bureau (NPCB) as to its compliance with

GMP, as well as an audit from the principal of the contract manufacturing business. I

observed that all those who entered the production area had to wear special dirt-resistant

attire, wearing head and shoe cover and a face mask. All personal belongings such as

handbags and mobile phones had to be kept in the lockers located in the changing room

adjacent to the entrance of the production department, according to GMP procedures for

ensuring cleanliness and preventing possible contamination of the products. The

movement inside the manufacturing suites was rather restricted within the work space

allocated to the operators. Apart from a quick briefing before the start of a shift, the

interactions among the operators in production suites were also somewhat limited. It

seemed to be natural for them to just enter the space allocated to them and start to input

the first item in their Batch Manufacturing Record (BMR), prepare the machine and run

the production.

The work in the manufacturing plant was organised around the machines. At most, two

people would handle one machine, although generally only a single person was

responsible for one machine in a shift. Every machine used in the production plant was

located inside a transparent room, the door of which had to be closed at all times. Outside

this room, there was a folder containing information about the process, including each

stage, the start time, the estimated time of completion and the estimated value of the

in a log book the events in a shift, such as the time taken at every stage of the production

process. This log book had to be checked by the supervisor every day. Despite wearing a

facemask, the smell of the material used to make the medicine gave me a real headache,

especially in the first few days of my visit. In addition, the smell of the medicines, the

sound of the machines and the air conditioner in the room sometimes made my

conversation with the operators difficult.

Every batch had its own BMR to record all the activities that happened during the

production process. The BMR was issued by the Quality Assurance (QA) department and

had to be returned completed to QA at the end of the process for approval before products

could be released to the warehouse department. Each batch for production started in the

dispensing department, which, on receiving the BMR, issued a Bill of Quantity to the

warehouse department requesting the material required. Ideally, the material requested

should have been sent out accordingly, on receipt of the Bill of Quantity. However, the

warehouse staff normally checked the amount of material held by the dispensing

department: if the system showed that there was a sufficient amount of material inside the

dispensing area, he would not send the materials out until the dispensing staff made a

phone call to ask for the material. In his view, this was important because once the

materials were in dispensing area they could be safe to use only up to seven days after

being dispensed. This procedure was mutually agreed as acceptable by both departments

although the failure to update the record inside the system would lead to the wrong

judgment, which occasionally created disruptions to the production process in the night

information in the BMR started from this point and moved from one process to another.

At each point, information had to be entered, such as the time taken for each process, the

weight of the product at certain intervals and its physical appearance, thickness and

hardness. The BMR had to be signed by the operator and countersigned by the

supervisors in that shift. At certain intervals, such as after compression in the case of the

manufacturing of tablets, the quality controller would check for dissolutions, appearance,

blister packs (for tablets) etc.